Sökresultat för "Medical Devices"

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. Are you an experienced regulatory leader who enjoys developing people, improving processes, and driving regulatory excellence in a global medical device environment? Then this could be the right role for you.About the role We are looking for an experienced Regulatory Affairs Manager to lead a team of 5 Regulatory Affairs Specialists supporting our global medical device portfolio. This is a key leadership role for someone who combines deep global regulatory expertise with proven people leadership. You will lead and develop a team responsible for global regulatory submissions and registrations, regulatory compliance, vigilance, post-market regulatory activities, and regulatory intelligence. Success in this role requires a leader who is strategic, pragmatic, hands-on, and passionate about developing people while driving operational excellence.   What you'll do   Manage a team of 5 Regulatory Affairs Specialists.   Manage resource planning and allocation across global regulatory activities.   Ensure high-quality execution of global regulatory submissions, product registrations, and other regulatory operational activities.   Own and continuously improve core regulatory processes and ways of working.   Support global post-market regulatory activities, including vigilance, Post-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), regulatory compliance, and regulatory intelligence.   Provide technical guidance and hands-on support to the team on complex regulatory matters.   Foster a collaborative, engaged, and high-performing team focused on delivering regulatory excellence.  Your profile  You are an experienced regulatory leader with a passion for developing people, improving processes, and supporting a global medical device organization. You are a pragmatic and collaborative leader who translates regulatory requirements into practical, efficient processes that ensure compliance while supporting the business. You thrive in dynamic environments, focus on what matters most, build strong cross-functional relationships, and are motivated by developing talent and driving the continued success of the organization. Experience & skills  Extensive Regulatory Affairs experience within the medical device industry,   Proven people management experience, with the ability to lead, coach, and develop regulatory professionals.  Expert knowledge of the European Medical Device Regulation (EU MDR).   Demonstrated experience leading global regulatory submissions and product registrations, experience with at least one of the following regulatory authorities is required: China (NMPA), Japan (PMDA), India (CDSCO), US (FDA)   Experience with medical device software and IEC 62304.   Experience with medical device standards such as ISO 13485 and ISO 14971.  Strong understanding of global medical device regulations throughout the product lifecycle, including medical device product development and design control processes.  Demonstrated ability to optimize regulatory operations, improve processes, and lead teams through organizational change.   Excellent planning, prioritization, and stakeholder management skills.   A pragmatic, positive, and solution-oriented leader who leads by example, takes ownership, and thrives in a dynamic environment.   Proficiency in English.  Meriting experience  US regulatory experience, Experience with FDA submissions, including eSTAR/510(k).  Experience with IEC 62366 and ISO 14155  Experience with regulatory intelligence, regulatory signal monitoring, and evolving global regulatory requirements.   Experience with Cybersecurity requirements for medical devices.  Experience with AI/ML-enabled medical devices.  Our Culture Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail.

Do you want to develop embedded software for medical devices that improve and save lives? Nexer Engineering is looking for Embedded Software Developers for assignments within the MedTech industry in Sweden. The focus is on embedded software development in regulated environments, with strong emphasis on product quality, patient safety, risk management, and compliance with medical device standards. Your role You will work throughout the embedded software development lifecycle, contributing to the development of safety-critical medical devices and systems. Responsibilities include: Developing and maintaining embedded software for medical devices Participating in software architecture and technical design activities Working with software verification, validation, and unit testing Contributing to risk management activities throughout the development process Supporting regulatory compliance and software documentation activities Collaborating closely with system engineers, quality teams, and cross-functional development teams Ensuring compliance with applicable medical device standards and development processes Your profile Proven experience in embedded software development Experience from the MedTech, Medical Device, Life Science, or other highly regulated industries Strong programming skills in Embedded C and/or C++ Experience developing software for embedded systems Understanding of software development in safety-critical or regulated environments Experience with software verification, validation, and testing activities Experience working throughout the complete software development lifecycle Ability to work in multidisciplinary product development teams Nice to have Experience working according to IEC 62304 Knowledge of medical device development processes and regulatory requirements Experience with risk management activities in product development Experience working with quality management systems in regulated environments Experience supporting audits, certifications, or regulatory submissions Swedish language skills Experience working within Swedish MedTech organizations Why Nexer Engineering? At Nexer Engineering, you will have the opportunity to work with innovative MedTech companies and contribute to products that have a direct impact on people's health and quality of life. We offer long-term assignments, strong technical communities, and opportunities to develop your expertise within embedded software, safety-critical systems, and regulated product development. Apply If you have experience in embedded software development and MedTech environments, and want to work with advanced products in a highly regulated industry, we would like to hear from you.

We pull medical technology from the future to solve human health.   Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. ABOUT THE ROLE Scarlet’s Quality Team ensures that innovative medical device companies meet the highest regulatory standards. We support cutting-edge healthtech through efficient, high-quality QMS audits. We’re expanding our auditor pool and are looking for part-time/contractor lead auditors who can independently deliver audits in line with Scarlet’s standards, approach, and culture. This role is suited for auditors who fulfil the relevant criteria to be authorised as a Lead Auditor in a Certification or Notified Body under ISO 13485, EU MDR, and UK MDR. You will work flexibly, supporting audit delivery as part of Scarlet’s notified body activities. YOUR RESPONSIBILITIES * Conduct remote audits of medical device manufacturers’ Quality Management Systems under ISO 13485, EU MDR, and UK MDR. * Provide clear, structured audit documentation and evidence-based conclusions. * Contribute to consistent, high-quality audit experiences aligned with Scarlet’s audit methodology and values. REQUIRED QUALIFICATIONS & EXPERIENCE * Education * Bachelor’s degree in: * software engineering * computer science * physics or biophysics * biology or microbiology * chemistry or biochemistry * electrical, electronic, mechanical engineering or bioengineering * human physiology * medicine * pharmacy * Professional experience * Minimum 4 years of experience in the medical device industry * Minimum 2 years of experience auditing or managing QMSs under: * ISO 13485 * EU MDR and/or UK MDR * Preferred: Practical experience working with software. * Auditing experience * Prior work with notified bodies or accreditation bodies as a Lead Auditor * Technical experience * Experience with software medical devices (SaMD) is strongly preferred * Working knowledge of relevant standards, such as: * ISO 14971 * IEC 62304 * IEC 82304 * Cybersecurity WHAT WE’RE LOOKING FOR * Strong regulatory judgement — you are confident in interpreting and applying regulatory requirements. * Consistency & quality focus — you care deeply about audit quality and repeatability. * Clear communicator — you explain findings and requirements clearly and constructively. * Independent & reliable — you can deliver audits with minimal oversight * Aligned mindset — you are open to adopting Scarlet’s values, audit methods and tooling. ENGAGEMENT MODEL * Consultant auditor role * Fully remote * Flexible scheduling, subject to audit demand and availability INTERVIEW PROCESS * Introductory call with Emily (45 min) * Auditor competence & regulatory interview with a Scarlet auditor (45 min) * Case study with Johan * Complete a case study (maximum 60 min) * Present the case study (30 min) * References * Offer & onboarding

At Neoventa, we develop fetal monitoring solutions that help clinicians make critical decisions during childbirth. We are looking for a Technical Product Manager to take lifecycle responsibility for our fetal/maternal monitoring platform. About the role You will own our fetal/maternal monitoring platform, including CTG and fetal ECG/ST analysis, and guide it throughout its lifecycle—from requirements to development, release, and continuous improvements. Working closely with R&D, Clinical, Regulatory, Quality, Commercial teams, and external partners, you will turn user needs into safe, compliant, and meaningful products. The role is based at our HQ in Mölndal, reporting to the Chief Technology Officer. What you will do Own the products' roadmap and technical backlog Translate clinical and user needs into product and system requirements Drive technical decisions together with the rest of the R&D team Ensure solutions meet safety, regulatory, and commercial requirements Contribute to verification, validation, and product release Analyze field performance and drive continuous improvement Act as the technical expert internally and externally Your profile Engineering degree (Biomedical, Electrical, Software, Systems or similar) 8+ years of experience in technical product management, systems engineering or similar Experience from active medical devices (or other regulated industries) Strong understanding of embedded systems, signal processing, and HW/SW integration Fluent in professional English Who you are You combine deep technical curiosity with a strong sense of ownership You are comfortable navigating complexity and making sound decisions with incomplete information You are a collaborative problemsolver with a can-do attitude You communicate with clarity and adapt your message to your audience You focus on what creates real value - balancing technical possibilities with clinical and business needs Why join us? This is a unique opportunity to become the techincal product manager for a complex medical device and help shape the future of fetal monitoring. You'll work at the intersection of technology, clinical practice, and innovation - where your professionallism will have a direct impact on healthcare professionals, mothers, and babies worldwide. To apply  Neoventa is committed to sustainability and diversity and encourages applicants from all backgrounds.  The application deadline is August 9th, 2026. Due to the summer vacation candidate selection and interviews will be done after the application period. We do not accept applications via email or phone; instead, we kindly ask you to apply directly through our career website.  If you have any questions regarding the recruitment process or the position, you are welcome to contact Thomas Börstell, Chief Technology Officer, thomas.borstell@neoventa.com or Frida Svenningsson, Chief People & Culture Officer, frida.svenningsson@neoventa.com.  We look forward to receiving your application!

About Sunmedic Sunmedic is a forward-thinking medical device company dedicated to delivering innovative, safe, and effective products for patients. We’re seeking a results-driven Marketing Specialist to join our team and help grow our brand, generate demand, and support product launches across markets. This role offers the opportunity to shape go-to-market strategies, collaborate with cross-functional teams, and play a pivotal role in bringing life-saving devices to patients. What you’ll do Develop and execute integrated marketing campaigns across digital and traditional channels to drive product awareness and demand. Collaborate with Product manager, Sales, Regulatory, and Medical Affairs to create compelling messaging, positioning, and value propositions for target segments. Manage content creation (website, blogs, case studies, brochures, social media) and lifecycle activities aligned with product launches and lifecycle management. Plan and optimize digital marketing efforts (SEO/SEM, social media, analytics) to achieve lead generation and pipeline goals. Analyze market trends, customer insights, and competitive landscape to inform strategy and tactics. Support events, webinars, and trade shows; coordinate collateral and speaker opportunities. Measure, report, and optimize campaign performance with clear KPI dashboards. Ansvara för marknadsstrategi: ta fram och driva marknadsstrategi och handlingsplan för tillväxt, i linje med bolagets mål Marknadsplan och genomförande: planera, prioritera och följa upp aktiviteter (kanalstrategi, kampanjer, lanseringar) Marketing av nya sårvårdsprodukter: ta huvudansvar för planering och genomförande av marknadsaktiviteter kopplade till nya produkter (go-to-market, lanseringsplaner, kampanjer och material) Kommersiell utveckling: bidra till mål för pipeline/leadsgenerering, försäljningstillväxt och ökad marknadsandel (tillsammans med distributörer) Segment och målgrupper: utveckla segmentering och säkerställa att budskap och erbjudanden matchar behov hos relevanta målgrupper Varumärke och positionering: säkra att varumärkesplattform och kommunikation är konsekvent och tydlig Ensure regulatory and compliance: Ensure brand consistency and adherence to regulatory/compliance considerations in marketing materials. Marknadskunskap och analys: följa marknadsdata, kundinsikter och konkurrensläge samt omsätta detta i förbättringar Budget och KPI:er: ansvara för marknadsbudget samt rapportera KPI:er och resultat (ROI, leadflöden, konvertering, aktiviteter som ger effekt) Samordning internt: nära samarbete med produktion, kvalitet/QA, logistik, produktutveckling och ledning för att säkerställa att marknadens planer är genomförbara och i rätt kvalitet Who you are A creative, data-driven marketer with a growth mindset and a collaborative approach. Strong storyteller who can translate complex medical device value into clear, compelling messaging. Results-oriented with excellent project management and prioritization skills. Comfortable working in a fast-paced environment and cross-functional teams. Clear communicator with the ability to engage both technical and non-technical stakeholders. What you have Education: Bachelor’s degree in Marketing, Communications, Business, Life Sciences, or a related field. Experience: >2 years of marketing experience, preferably in medical devices or healthcare; B2B experience a plus. Digital skills: Proficiency with marketing automation (e.g., HubSpot, Marketo), CRM (e.g., Salesforce), Google Analytics, SEO/SEM, and social media management. Language: Proficiency in English (written and spoken); additional languages a plus. Skills: Strong written and verbal communication; compelling content creation. Ability to analyze data, derive insights, and translate into action. Project management, budgeting, and vendor coordination abilities. Design sense for basic visuals or familiarity with design tools is a plus. Knowledge of regulatory considerations for medical devices in marketing materials is a plus. Nice-to-have Experience supporting product launches or lifecycle marketing in a regulated industry. Experience with events, webinars, and field marketing. Knowledge of ISO 13485-related processes or quality systems awareness. What we offer Competitive salary and benefits. Flexible work arrangements and a collaborative, innovative culture. Opportunities for professional growth and meaningful impact in the medical device field. How to apply Share your resume/CV and a brief cover letter outlining your marketing experience and why you’re interested in Sunmedic to abbas.karladani@sunmedic.se. If you’d like, include links to notable campaigns, case studies, or programs you’ve led. Öppen för alla Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. Are you a driven regulatory professional who enjoys ownership, collaboration and working close to product development? This could be the role for you. Apply and help shape the future of medical device software at RaySearch.About the role  We are looking for an experienced and driven Regulatory Lead to own the regulatory strategy and lifecycle oversight for one of RaySearch's products. In this role, you will be the regulatory point of contact for the product, working closely with key stakeholders in the Development, Corporate Strategy and Sales teams. You will help shape product strategy, guide development activities, drive market access, and ensure compliance throughout the product lifecycle.  This is a highly visible role for someone who enjoys combining deep regulatory expertise with strategic thinking, project coordination, and collaboration across the organization.  What you'll do  Own and drive the global regulatory strategy for your product throughout its lifecycle.  Lead the preparation, review, and maintenance of Technical Documentation and regulatory submissions, including EU MDR.  Act as the regulatory expert within development projects and ensure regulatory requirements are integrated throughout the design and development process.  Coordinate and oversee multiple projects, priorities, and submission timelines while maintaining a long-term view of the product roadmap.  Partner closely with Development, Corporate Strategy, Sales and other key stakeholders to support product development and market access.  Support inspections, audits, post-market activities, and continuous improvements.  Your profile  You are a proactive and pragmatic regulatory professional who enjoys taking ownership and driving things forward. You are technically strong, comfortable working with development teams, and able to translate complex regulatory requirements into practical solutions.  You like having oversight of the full product picture—from early development and regulatory strategy to submission and post-market activities—and you thrive in a collaborative, fast-paced environment where you can make a real impact.  Requirements  Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.  Several years of Regulatory Affairs experience within the medical device industry.  Strong experience preparing and reviewing Technical Documentation under EU MDR.  Experience working with medical device product development and design control processes.  Experience with medical device software  Strong knowledge of IEC 62304, IEC 60601 and ISO 14971  Strong project management and stakeholder management skills.  Ability to manage multiple activities and timelines while maintaining the bigger picture.  Proficiency in English.  Meriting experience  US regulatory experience, Experience with FDA submissions, including eSTAR/510(k).  Experience with IEC 62366 and ISO 14155  Experience with Cybersecurity requirements for medical devices.  Experience with AI/ML-enabled medical devices.  Our Culture Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail.

Surgical Science is a global organisation and leading provider of medical training simulations and software solutions. Surgical Science is listed on Nasdaq First North Growth Market.   Together with healthcare partners and customers in more than 90 countries, we enhance patient safety and healthcare outcomes through evidence-based, state-of-the-art simulation technology that improves clinical proficiency and performance - enabling safe and effective training without putting patients at risk.   Our solutions are used by medical training centres, universities, hospitals, and the medical device industry for practice, assessment, and certification.   With offices in Gothenburg (HQ), Stockholm, Tel Aviv, Cleveland, Cardiff, and Shenzhen, we are a fast-growing and stable organisation in a rapidly evolving world. We foster a hybrid work culture that supports onsite and remote collaboration across teams and time zones.   What if your attention to detail helped a surgeon perform better — and a patient recover faster?   At Surgical Science, we build the simulators that train surgeons before they ever step into an operating room. Our haptic feedback devices, anatomical models, and instrument simulators are used by healthcare professionals across the globe to sharpen their skills in a safe, controlled environment. The stakes are real — and so is the impact of getting quality right.   We're looking for a QC Engineer to join our Quality Control team at our production facility in Gothenburg, Sweden. You will work at the heart of our manufacturing operations — where precision meets purpose.   What you'll actually do Own end-to-end QC test plans: analyze product requirements and design detailed test cases that cover functional, integration, regression, and system scenarios Validate surgical instrument simulators, anatomical models with sensors, and haptic feedback devices — making sure every unit that leaves our facility meets the highest standards Calibrate measurement equipment and simulator components to maintain accuracy across the production line Perform acceptance testing on incoming components and vendor-supplied parts Conduct production line quality checks and sign off on systems meeting specification Dig into complex defects — trace root causes, document findings, and work with production and development to resolve them Participate in requirements reviews, bringing the QC lens early in the product lifecycle Maintain and improve test documentation, calibration procedures, and QC processes   What you need to bring 2–5 years of hands-on QC testing experience, ideally in a hardware/software environment Solid knowledge of QC testing methodologies and test documentation standards (STD/STP/STR) Experience with calibration procedures and measurement equipment Proficiency in quality management tools such as Dynamics and iAuditor Comfortable working in both Windows and Linux environments Strong written and spoken English — you'll collaborate across teams and time zones A sharp analytical mind and the ability to manage multiple priorities without dropping the ball This role is on-site at our Gothenburg, Sweden facility   Even better if you have Background in medical devices, simulators, or similar hardware/software industries Previous QC experience at a company with a comparable product complexity Familiarity with full product development lifecycles in a regulated environment   Where this can take you The QC Engineer role is a real foundation for growth. You could develop into a Senior QC Engineer or take on a team lead position as we scale. Our cross-functional setup means you'll build deep relationships across production, R&D, and software — opening doors to specialized paths in quality systems, validation engineering, or product development.   You'll also work with colleagues across Sweden, the US, and beyond, giving you exposure to international ways of working in a company that's been at the forefront of medical simulation for over 25 years.   Life at Surgical Science 🌍 Truly global environment — we're a team of 10+ nationalities united by a shared mission 🏥 Work that matters — every simulator we build contributes to safer patient outcomes 🤝 Collaborative culture grounded in respect, curiosity, and perseverance 📈 A growing company with real opportunities to develop your career 🔬 Work with cutting-edge simulation technology that's backed by 400+ scientific publications   Surgical Science as an employer Surgical Science is a global and continuously expanding organisation. You will be part of a dynamic, creative environment where we make sure to allow all employees to influence and contribute with their own unique experiences and knowledge.   Guided by our core values -  curiosity, respect, and perseverance - we strive to empower our people by recognising their strengths, supporting their growth, and creating opportunities to make a real impact.   We invite you to join us on this exciting and meaningful journey - to shape the future of medical training and improve care for patients around the world.   Apply today! If you think you would fit our fantastic team and enjoy our work environment, apply as soon as possible as recruitment is ongoing. Let us meet and work out together whether we are a match!We kindly request that you apply with a CV in English.

Surgical Science is a global organisation and leading provider of medical training simulations and software solutions. Surgical Science is listed on Nasdaq First North Growth Market.   Together with healthcare partners and customers in more than 90 countries, we enhance patient safety and healthcare outcomes through evidence-based, state-of-the-art simulation technology that improves clinical proficiency and performance - enabling safe and effective training without putting patients at risk.   Our solutions are used by medical training centres, universities, hospitals, and the medical device industry for practice, assessment, and certification.   With offices in Gothenburg (HQ), Stockholm, Tel Aviv, Cleveland, Cardiff, and Shenzhen, we are a fast-growing and stable organisation in a rapidly evolving world. We foster a hybrid work culture that supports onsite and remote collaboration across teams and time zones.   Most production managers make widgets. You'll make the simulators that train surgeons.   Surgical Science's products are used in hospitals and training centers across the globe to help clinicians build the skills they need before they ever operate on a real patient. Behind every simulator that ships from our Gothenburg facility is a production team that has to get it right — every time.   We're looking for an Operations & Production Manager to lead that team. Based at our headquarters in Gothenburg, you'll oversee production, build, and warehouse operations and be the driving force behind output, quality, and efficiency. You'll report directly to the COO and play a central role in how we scale our manufacturing capabilities as the company grows. This is a hands-on leadership role for someone who genuinely loves the craft of operational excellence — and who understands that the people running the floor are the engine of everything.   What you'll actually do Lead and develop our production, build, and warehouse teams — setting direction, maintaining standards, and building a culture where people do their best work Own production planning and scheduling, balancing capacity, delivery commitments, and resource constraints in a dynamic, fast-moving environment Define and monitor KPIs across the full production operation and drive structured improvement when targets aren't met Champion continuous improvement — whether that's lean practices, workflow redesign, or tooling upgrades, you'll find and close the gaps Ensure full compliance with safety and quality standards across all production activities Manage budgets and resources — workforce, materials, and equipment — with both short-term delivery and long-term sustainability in mind Collaborate closely with QC, R&D, and supply chain to keep product launches on track and production issues resolved fast Own the people side of your operation: hiring, onboarding, developing, and when necessary, managing performance and exits   What you need to bring 5–8 years of production or operations management experience, with a track record of leading teams and delivering results in a manufacturing environment Strong understanding of production planning, capacity management, and shop floor operations Experience with continuous improvement methodologies (Lean, 5S, Kaizen, or similar) A natural people leader — someone who builds trust on the floor, sets clear expectations, and develops talent over time Sharp analytical skills: you read KPI dashboards, find root causes, and act on data — not instinct alone Clear communicator in English (Swedish is a plus); comfortable engaging with both the production floor and senior stakeholders Proficient with Microsoft Office and production management tools   Even better if you have Background in medical devices, electronics, or complex hardware manufacturing Experience in a quality-regulated or ISO-certified production environment Familiarity with ERP systems and production scheduling software Experience scaling a production operation during a period of company growth   Where this can take you As Surgical Science expands its product portfolio and increases production volumes, the scope of this role grows with it. The natural next step is broader operational leadership — with visibility into supply chain, facilities, and global manufacturing strategy. You'll work at the centre of a company that has been growing consistently, backed by over 25 years of innovation in medical simulation.   You'll also be building something: a production function that matches the ambition of our products and the trust our healthcare customers place in us.   Life at Surgical Science 🌍 Global company, Swedish roots — HQ in the heart of Gothenburg 🏥 Products that genuinely impact patient safety worldwide 💻 Hybrid work flexibility ⌚ Flexible working hours 📈 A growing company with real investment in its people and operations 🤝 Culture built on respect, curiosity, and perseverance   Surgical Science as an employer Surgical Science is a global and continuously expanding organisation. You will be part of a dynamic, creative environment where we make sure to allow all employees to influence and contribute with their own unique experiences and knowledge.   Guided by our core values -  curiosity, respect, and perseverance - we strive to empower our people by recognising their strengths, supporting their growth, and creating opportunities to make a real impact.   We invite you to join us on this exciting and meaningful journey - to shape the future of medical training and improve care for patients around the world.   Apply today! If you think you would fit our fantastic team and enjoy our work environment, apply as soon as possible as recruitment is ongoing. Let us meet and work out together whether we are a match!We kindly request that you apply with a CV in English.

Surgical Science is a global organisation and leading provider of medical training simulations and software solutions. Surgical Science is listed on Nasdaq First North Growth Market. Together with healthcare partners and customers in more than 90 countries, we enhance patient safety and healthcare outcomes through evidence-based, state-of-the-art simulation technology that improves clinical proficiency and performance - enabling safe and effective training without putting patients at risk. Our solutions are used by medical training centres, universities, hospitals, and the medical device industry for practice, assessment, and certification. With offices in Gothenburg (HQ), Stockholm, Tel Aviv, Cleveland, Cardiff, and Shenzhen, we are a fast-growing and stable organisation in a rapidly evolving world. We foster a hybrid work culture that supports onsite and remote collaboration across teams and time zones.   Job Overview This role focuses on hands-on support of our medical simulators throughout the customer lifecycle. You will be involved in pre-sale demonstrations, post-sale Installation and training, and ongoing customer education. The position is customer-facing, requires frequent travel, and involves close collaboration with internal teams and regional partners.   This position will be based in Gothenburg, Sweden, but we may also consider candidates based in Stockholm.   Responsibilities Deliver pre-sale product demonstrations to customers, partners, and distributors, often with doctors, clinicians and medical industry professionals. Conduct post-sale training sessions, including on-site and online trainings Support simulator installations, workshops, and customer onboarding activities Serve as a product and application expert, providing guidance on system usage and best practices Participate in regional and international conferences, exhibitions, and customer events Share customer feedback and field insights with Sales, Product, and R&D teams   Your profile We are looking for a dynamic and adaptable professional with experience in clinical or field-based training. Prior clinical experience is highly valued, enabling effective collaboration with healthcare and industry professionals. You thrive in a fast-paced international environment and combine strong technical aptitude with excellent communication, organizational, and training skills.   Qualifications & Experience Educational or professional background in healthcare, life sciences, medical technology, or related fields (e.g., biology, medical sciences, biomedical/medical engineering, nursing, or medicine) Experience in customer-facing roles such as training, clinical support, application support, or education is advantageous Experience working with medical devices, simulators, or other advanced technical systems is considered a strong asset Strong presentation, communication, and instructional skills Technical aptitude with the ability to troubleshoot and resolve system-related issues Excellent organizational and time-management skills Fluent in English; additional languages are an advantage Willingness and ability to travel frequently (approximately 50–60%), often on short notice, primarily within Europe   Personal Attributes Self-driven, reliable, and responsible Customer-oriented with strong interpersonal and relationship-building skills Adaptable and comfortable working in an international environment with changing priorities and schedules Curious, hands-on, and motivated to continuously learn new technologies   Why join us? A meaningful and technology driven mission. Our technology combines the intersection of software and healthcare. A role like nothing you will have experienced. Travel around the world to support global healthcare institutions. We offer trust, autonomy, and career growth.   Surgical Science as an employer Surgical Science is a global and continuously expanding organisation. You will be part of a dynamic, creative environment where we make sure to allow all employees to influence and contribute with their own unique experiences and knowledge. Guided by our core values -  curiosity, respect, and perseverance - we strive to empower our people by recognising their strengths, supporting their growth, and creating opportunities to make a real impact. We invite you to join us on this exciting and meaningful journey - to shape the future of medical training and improve care for patients around the world.   Apply today! If you think you would fit our fantastic team and enjoy our work environment, apply as soon as possible as recruitment is ongoing. Let us meet and work out together whether we are a match! We kindly request that you apply with a CV in English.

About the Role As a Global Regulatory Specialist, you will join our Quality & Regulatory Affairs team to help ensure our medical devices and mounting systems meet global regulatory requirements. Please note: This is a hybrid role with 1–3 days per week onsite at our Stockholm office in Östermalm, especially during onboarding. Occasional international travel (10–20%) may be required and will be communicated in advance. In this role you will: Streamline regulatory processes and set a roadmap in collaboration Product & Development, QA, and Operations teams. Coordinate with internal and external auditors to support audit readiness. Review device classifications and regulatory challenges across markets. Maintain and update technical documentation (Annex II & III) and declarations of conformity, including EU Declaration of Conformity, in alignment with the associated technical documentation. Coordinate establishment of registrations and device listings with the FDA, Authorized Representatives, and Importers/Distributors. Support product registrations and market access activities (EU MDR Class I, FDA 510(k)-exempt Class II). Monitor regulatory changes and communicate implications to relevant teams. What We’re Looking For We are looking for a structured and collaborative regulatory professional who enjoys solving problems with a logical approach, works autonomously while contributing to strategic initiatives, and thrives in a dynamic, cross-functional environment. We’re looking for a detail-oriented and analytical professional with: A bachelor’s degree in Regulatory Affairs, Life Sciences, Electrical-Electronics or a related field. At least 5 years of experience in medical device regulatory affairs with hands-on experience with EU MDR (Class I) and FDA QSR. Experience with regulatory systems, document control tools, and QMS platforms and exposure to technical documentation, internal and external audits for regulatory compliance Strong organization, coordination and communication skills to engage auditors and communicating with stakeholders across functions and levels. Ability to break down complex regulatory topics clearly for both technical and non-technical stakeholders. Proficiency in both spoken and written communication in English. Ideal candidates will bring: Familiarity with embedded systems and experience with IEC 62304. Experience with EU MDR (Class II/III).

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. Are you passionate about ensuring that complex medical software is secure, resilient, and fully compliant with international standards? As Risk Manager, you will take ownership of identifying and mitigating risks within cybersecurity and information security across our products. With a structured mindset and keen attention to detail, you will play a central role in maintaining the integrity, reliability, and compliance of our software solutions. About the job As Risk Manager, you will be responsible for identifying, assessing, and mitigating cybersecurity and information security risks across all RaySearch products. As part of a smaller cybersecurity group, you will work with all aspects of cybersecurity for our product delivery including compliance, threat modelling, developer training, penetration testing, tooling and more. Your responsibilities will span the entire product lifecycle, with a particular focus on cloud-based solutions and secure software development practices. You will collaborate closely with development teams across the organization and work alongside other Risk Managers to ensure comprehensive risk management and compliance with international standards. Main responsibilities Participate in project planning together with the project management team. Support the development team with risk management related tasks, e.g., ensuring that the risk management process is applied, taking part in design and risk analysis of new and changed functionality and ensuring that risks are appropriately mitigated and tested. Own and maintain the project’s risk management documentation. Coordinate cybersecurity management activities within product development and the secure software development life cycle (SSDLC). Own the development and maintenance of cybersecurity documentation for regulated products, including FDA-related cybersecurity requirements and frameworks.  Your profile We are looking for someone who understands the importance of risk management in medical software and is motivated by working in this field with all the responsibilities it entails. You are responsible, meticulous and structured, with a strong personal drive and the ability to work independently in a highly organized and efficient manner. You have experience working with or alongside software development teams and possess a strong technical understanding of software development processes, enabling you to navigate complex software environments and collaborate effectively with technical stakeholders. Requirements: BSc or MSc degree in engineering, or equivalent.  3+ years' experience working in a software development environment with complex software products. Excellent written and spoken communication skills (English and Swedish).   Meriting: Experience from the medtech industry or other regulated or safety critical industries.  Experience of device risk management.  Experience with product safety standard requirements for medical devices (IEC/ISO standards, e.g., ISO 14971).  Leadership or project management experience.  Experience as a system developer.  Our Culture Culture at RaySeach is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by email.

Drive innovation where it matters Make your next move matter At Mölnlycke, we believe that real impact starts with people. People who are bold enough to challenge the status quo. People who care deeply about their work, their colleagues, and the world around them. People who know exactly why they do what they do. As a global medical solutions company, we design and deliver innovative products and services across wound care, operating room solutions, gloves, and antiseptics. Our mission is to advance performance in healthcare by supporting professionals, improving outcomes, and making a difference where it matters most. In Wound Care, we help to prevent, manage and accelerate the healing of wounds. Where you’ll make a difference Mölnlycke is now looking for a Packaging Developer to join our R&D Wound Care Packaging & Artwork team at our headquarters. In this role, you’ll contribute to meaningful work that improves lives. You will collaborate across teams, bring your ideas to the table, and help shape innovative packaging solutions that support both patients and healthcare professionals. Here’s how you’ll make an impact: Drive and execute packaging change projects with defined scope and impact Develop and implement new or improved packaging solutions to meet customer needs and regulatory requirements Own technical documentation and ensure compliance with global standards for medical device packaging Collaborate with procurement and suppliers, leading technical discussions, support audits, and build partnerships Identify and propose new packaging technologies, materials, and suppliers Act as a key contributor in cross-functional teams including R&D, project management, and process development Support sustainability initiatives through development of smarter, more sustainable packaging solutions What you’ll get Be part of a culture built on trust, care, and shared ownership. Your growth and development Opportunities to expand your expertise in packaging and medical device development Exposure to cross-functional collaboration and strategic decision-making Potential career paths into senior development roles, project management, or leadership Flexibility, wellbeing and benefits A collaborative, supportive, and highly experienced team environment Opportunities to make a real difference for customers, patients, and the environment Competitive compensation and benefits package A workplace that values wellbeing, inclusion, and continuous improvement What you bring We’re looking for someone who combines technical expertise with curiosity and a collaborative mindset. Must-haves Bachelor’s or Master’s degree in engineering, chemistry, life sciences, or equivalent Around 5 years’ experience in product/material development from medical devices, or packaging development from other regulated industry Fluent English, written and spoken Strong communication and stakeholder collaboration skills Key strengths and mindset High level of accuracy and attention to detail A collaborative, positive, and solution-oriented approach Curiosity and a genuine interest in sustainable packaging innovation and development Ability to balance technical rigor with business needs Nice to have Experience working with packaging materials such as paper, plastics, or bottles Interest or experience in sustainable packaging solutions Strong knowledge of design control and regulated environments Understanding of global regulatory requirements for packaging Please submit your application by August 9th. As we approach the holiday season, interviews are planned to take place in August. Our approach to Diversity & Inclusion We’re building a workplace where everyone feels seen, heard, and valued. We believe that a diverse mix of people makes us stronger—bringing fresh perspectives, driving better decisions, and helping us deliver solutions that reflect the world we serve. Inclusion isn’t just a value—it’s how we work, grow, and lead together. About Mölnlycke Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. Our business is organised in four business areas: Wound Care, Operating Room Solutions, Gloves and Antiseptics, with customer centricity, sustainability and digitalisation at the heart of everything we do. We employ around 8,700 people globally, with headquarters in Gothenburg, Sweden, and operations in more than 100 countries. Mölnlycke is a founding partner of GoCo Health Innovation City and has been part of Investor AB since 2007.

At the Vitrolife Group, we work every day to unlock the full potential of science and technology to reduce the barriers towards building a family. Together we help our customers and their patients to fulfill the dream of having a baby. Shape the Decisions Behind Our Product Model — Not Just the Diagrams Are you energized by architecting for empowered product teams rather than for a control room? We're looking for an Enterprise Architect to guide Vitrolife Group through our shift from project-driven delivery to a domain-based product operating model — in a MedTech setting where regulation, AI governance, and platform engineering all have to work together from day one. Your Mission You'll architect for team autonomy and clear domain boundaries, govern through decision records instead of review-board theatre, and treat regulatory constraints (SaMD, IEC 62304, MDR/IVDR) as inputs to design rather than a documentation exercise at the end. You'll also help define how AI is governed across the enterprise, and how AI is used responsibly within the architecture practice itself. What You'll Do * Architect for empowered, autonomous product teams aligned to business domains, not a central control point * Own canonical domain and data models across the organization, including alignment to standards like FHIR R5 where relevant * Write and review architecture decision records (ADR/LDDR) as the primary governance mechanism * Define enforceable, auditable guardrails for agentic AI systems, aligned to the EU AI Act * Bring SaMD classification, ISO 14971, IEC 62304, and MDR/IVDR cybersecurity requirements into architecture decisions from the start * Champion Team Topologies, platform engineering, and governance-as-code across delivery pipelines What You Bring * Proven experience as an enterprise, solution, or lead architect in a product-operating-model or platform-engineering context * Strong grounding in domain-driven design, capability mapping, and canonical data modeling * Comfort with Azure landing zone architecture, Terraform, and modern CI/CD (OIDC, GitHub Enterprise Cloud) * A track record of governing through decision records and paved paths rather than central approval gates * The instinct to separate governing AI from using AI — and to keep accountability for outcomes either way * An enabler mindset: you see internal teams as customers of the platform, not requesters in a queue Bonus Points For (Highly Desired for This Role) * Experience in MedTech, life sciences, or another regulated industry (MDR/IVDR, ISO 13485, IEC 62366, IEC 81001-5-1) * Familiarity with FHIR and healthcare data interoperability standards * Experience embedding SBOM, SLSA, or STRIDE-based threat modeling into delivery pipelines * Exposure to .NET / C# backend architecture and vertical slice design * Experience with fine-grained authorization models (e.g. OpenFGA) alongside Entra ID Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We support our customers by improving their clinical practice for the patient's outcome of fertility treatment. We are currently approximately 1 100 colleagues worldwide, with headquarters in Gothenburg, Sweden. Vitrolife Group's products and services are available in more than 110 countries through our own presence in 30 countries and a network of distributors. Vitrolife Group is a sustainable market leader and aims to be the preferred partner for IVF-clinics by providing superior products and services with the vision of fulfilling the dream of having a baby. The Vitrolife share is listed on Nasdaq Stockholm.

RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination. We are looking for a System Developer who can blend software development expertise with a strong interest in security. In this role, you’ll contribute directly to RaySearch’s mission: advancing cancer treatment through innovative software. By ensuring that our products are designed and implemented securely, you help protect both patients and healthcare professionals and strengthen the reliability of the tools they depend on. About the role As a System Developer within cybersecurity, you will play a key role in shaping our secure development practices. You will work closely with development teams to embed security into the software development lifecycle and ensure that our products follow industry-leading standards. The role combines hands-on application security work—such as secure code reviews, threat modeling, and penetration testing—with knowledge sharing, training, and collaborative support to help teams make informed security decisions. This is an ideal role for a developer who enjoys cybersecurity and wants to contribute by guiding others, elevating security awareness, and helping teams work securely and effectively together. Your main tasks Work with development teams to implement application security best practices throughout the SDLC. Participate in threat modeling (e.g., STRIDE) and risk assessments for new and existing applications. Assist in designing and implementing cybersecurity controls in products. Ensure compliance with cybersecurity frameworks and standards. Contribute to developer security awareness training and promote secure development practices. Perform secure code reviews, static/dynamic analysis, and penetration testing. Develop and maintain secure coding guidelines and security documentation. Support the preparation of cybersecurity documentation for regulated products (including FDA-related frameworks). Your profile You are a developer with a strong interest in cybersecurity and secure design. You enjoy sharing knowledge, collaborating with others, and supporting development teams in building secure solutions. You communicate clearly, work constructively across functions, and contribute to a culture where security is a natural part of everyday development. Required skills Strong understanding of software development practices and the ability to read, analyze, and evaluate code for security and quality aspects.  Strong understanding of application security principles (e.g., OWASP Top 10, secure coding). Experience with threat modeling and risk analysis. Excellent ability to produce clear, structured security and compliance documentation. It’s an advantage, but not required, if you also have experience of: Working in regulated environments (e.g., medical devices, embedded systems). Hands-on experience with security testing tools (e.g., SonarQube, Burp Suite). Familiarity with FDA cybersecurity guidelines, the IEC 8100x series, or IEC 62443 for industrial/embedded systems. Integrating security into CI/CD pipelines (Azure DevOps or GitHub Actions). Our Culture Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care. Our Offer At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package. Application Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail.

We are looking for an Account Manager for Norway – welcome to Ottobock Scandinavia! Join a global leader in health technology and help improve mobility and quality of life. In this role, you will work closely with healthcare professionals and drive growth in the Nordic market. About us Ottobock is a global leader in health technology, prosthetics, and orthotics, dedicated to improving quality of life and supporting mobility worldwide. As part of our Scandinavian sales team, we are committed to delivering innovative solutions and outstanding customer service to healthcare professionals and end users. About the Role As an Account Manager for Norway in the Scandinavian sales team you will play a role being responsible for managing existing customer relationships and acquiring new clients. The role includes supporting our customers with high-quality advice and technical expertise focusing on our neuro orthotic and prosthetic product segment, contributing to increased product knowledge and user satisfaction. You will work closely with various healthcare stakeholders, building strong connections across different sectors. Our Offer The position is a full time permanent position with placement in a home based office in Norway. Working hours are variable and travel within the Nordic region is part of the job. Start date is set by agreement. We offer dynamic and developing work in an international environment with the opportunity to influence and shape the future market within O&P sector. You will become part of our Nordic sales team and have access to continuous training and professional development. You will report to our Sales manager for Ottobock Scandinavia. You will be provided with all the necessary tools, training, and support to succeed in your role. About You You have a CPO education or similar and preferably experience in sales. Previous experience for more than five years in the field of medical devices is advantageous. You are proactive, results-driven, and enjoy building strong relationships with clients and partners. You are based in Norway and comfortable with travel and thrive in an independent role while still being a valuable part of a collaborative team. You are fluent in English and Norwegian and have good computer skills. You take independent responsibility for your tasks, thrive your own processes forward, and ensure they are completed. You work proactively and independently, translating ideas into practical actions. When problems arise, you focus your energy on finding solutions while keeping eyes on the goal. You are trustworthy and an outgoing as a person who easily build and maintain good customer relationships. How to apply Last day of application is 2026-08-16. If you have any questions about the position, please contact Frida Wassborn, Sales Manager, frida.wassborn@ottobock.se. The selection process is ongoing, and the position may be filled before the closing date. Please visit our websites for more information: www.ottobock.se We strive to be an inclusive workplace, free from discrimination regardless of where you work within our organization. We value diversity and encourage individuals to bring different experiences, ways of expression, and perspectives. Diversity fosters innovation, and we believe it strengthens both our corporate culture and our way of working. We conduct standardized and equitable recruitment processes. All applicants are assessed fairly, without regard to gender, gender identity or expression, ethnicity, religion or other beliefs, disability, sexual orientation, age, or any other characteristic protected by applicable law.

Bohus Biotech is an innovative company focused on the development and manufacture of high-quality products containing hyaluronic acid (HA). We are now in an expansive phase, investing in the products and processes of the future. We are looking for a driven Process Engineer who wants to become part of Bohus’s future and contribute to the continued development of hyaluronic acid and its products. As our Process Engineer, you will be responsible for developing, optimizing, validating, and maintaining manufacturing processes to ensure product quality, process robustness, regulatory compliance, and operational efficiency. The role supports both existing production processes and the introduction of new products and technologies. You will be working closely with dedicated and highly competent colleagues within Production, Quality Assurance, Regulatory Affairs, Supply Chain, and R&D. You will get the exciting opportunity to build, shape and optimize our processes and apply your experience and expertise to ensure the highest manufacturing standards. If this sounds interesting to you - Come join us! This is a full-time position and based in our company location in Strömstad, Sweden. On-site in Strömstad preferred, but hybrid solutions are possible for the right candidate. We will interview candidates continuously and welcome your application today. Key responsibilities The Process Engineer is responsible for ensuring that manufacturing processes are robust, efficient, validated, and compliant throughout the product lifecycle. You will bridge day-to-day manufacturing support with longer-term process development and operational excellence initiatives. The position reports to the COO. Duties and responsibilities include: Develop, implement, and continuously improve manufacturing processes to enhance quality, yield, and efficiency. Lead root cause investigations and implement corrective and preventive actions (CAPA). Plan, execute, and document validation activities, including Process Validation, Equipment Qualification (IQ/OQ/PQ), Cleaning Validation, and Test Method Validation/Verification. Provide technical support to production, investigating process deviations, non-conformities, and out-of-specification results. Lead continuous improvement initiatives using structured problem-solving methods such as Root Cause Analysis, FMEA, and 5 Why. Ensure processes comply with ISO 13485, EU MDR 2017/745, ISO 14971, and GMP principles. Support audits and inspections by customers, regulatory authorities, and Notified Bodies. Support technology transfers from R&D to production and participate in cross-functional development projects. Approve process validation documentation according to delegated authority and escalate process risks impacting product quality, compliance, or supply. Skills and Competencies The suitable candidate has the following qualifications: Formal academic degree level (BSc. or MSc.) in chemical engineering, biotechnology, pharmaceutical science or related. Strong background in process engineering preferably combined with validation engineering experience. Experience working in a manufacturing environment within a regulated industry (e.g. Medical Devices, Pharmaceuticals, Biotechnology, or other regulated industries). Experience with process optimization, process validation and problem solving. Experience with sterile processes, equipment qualification (IQ, OQ, PQ), process validation, troubleshooting, and continuous improvement would be highly valuable. Experience working with Quality Management Systems. Knowledge of statistical analysis and process capability concepts. Excellent communication and documentation skills in English are required The successful candidate for this position will be someone who: Has a strong technical and analytical mindset. Enjoys solving complex manufacturing and process-related challenges. Is structured and detail-oriented. Takes ownership and drives improvements independently. Communicates effectively across departments and organizational levels. Combines hands-on problem solving with a systematic approach. Thrives in a fast-paced environment where quality, compliance, and operational performance are equally important. We offer a dynamic working environment with significant opportunity to make an impact — contributing to Bohus’s success as well as your own growth and development. About Bohus Biotech Founded in 1993, BOHUS has been at the forefront of Hyaluronic Acid (HA) development and manufacturing for over three decades. Our journey began with a vision to revolutionize the HA industry through innovation and commitment to excellence. With more than 30 years of expertise, the company has established a strong international presence with products distributed to hospitals, clinics, and physicians in over 60 countries worldwide. Bohus Biotech focuses exclusively on high quality hyaluronic acid technologies across three therapeutic areas: Ophthalmology – OVD solutions supporting tissue protection during cataract surgery Aesthetics – Dermal fillers based on the proprietary SHAPE™ technology platform Orthopaedics – Injectable treatments for osteoarthritis All research, development, and manufacturing are located in Strömstad, Sweden, ensuring full control over product quality and innovation. For more information, visit the company's web sites at: www.bohusbiotech.com For more information about this position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se