Sökresultat för "Regulatory requirements"

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).

Are you a confident expert in regulatory compliance with a strong customer focus and a passion for sharing knowledge? In this role, you’ll act as a trusted advisor to our customers, guiding them through regulatory requirements for market access — particularly across Europe. You’ll lead compliance projects, deliver expert training, and help shape and grow our Regulatory Compliance Project Management service. Key Responsibilities: · Help define and continuously develop and evolve our advisory service “Regulatory Compliance Project Management” · Advise customers on CE marking, UKCA, and EU regulatory requirements · Perform strategic compliance project management projects · Deliver training sessions and courses online and in-person · Support the sales team by identifying opportunities and contributing to business growth · Collaborate with colleagues and customers across international markets · Take ownership of your professional development while actively contributing to the growth and advancement of your area of responsibility Your background should involve: · Post-secondary degree or diploma in a relevant field or equivalent work experience · Excellent knowledge and experience of work with regulatory requirements, testing and certification of electrical products for market access · Strong knowledge within LVD, EMC, RED and MD · Strong knowledge of the CE marking process, in both theory and practice · Excellent communication skills, in both Swedish and English Ability to teach within the area of regulatory requirements for electrical products You combine strong technical expertise with a consultative, customer-focused approach. You thrive in a fast-paced, evolving environment and are able to adapt to changing priorities. You are both detail-oriented and strategic in your thinking, enabling you to see the bigger picture while maintaining high accuracy. You build strong relationships and inspire trust among colleagues and customers alike. You take ownership of your work and are driven to deliver results. Intertek offers: Meaningful work that contributes to product safety and reliability Opportunities for professional development and long-term career growth A collaborative and supportive work environment Exposure to a wide range of products, technologies, and industries The chance to work within a truly global organization Intertek is a leading Total Quality Assurance provider to industries worldwide. With a 125-year legacy of excellence, our global network delivers innovative and bespoke Assurance, Testing, Inspection, and Certification solutions for our customers' operations and supply chains. Our extensive global network of accredited laboratories and world-class experts are dedicated to addressing quality, safety, and sustainability across a vast spectrum of industries, including Medical, Lighting, Renewable Energy, HVACR, Appliances & Electronics, Connected World (IoT), and many more. Global manufacturers trust Intertek for faster, simpler, and more cost-efficient services that clear a path for their product's success. Join us and be a part of a team that continually exceeds client expectations and sets the standard for quality and accuracy.

Are you a structured and service-minded engineer with an eye for detail and regulations? Now you have the chance to become the regulatory anchor for our R&D projects and help our hardware products reach markets across the globe. Welcome to the Regulatory team within R&D in Lund! Your future team You'll become part of our Regulatory team within R&D in Lund - a group of seven experienced and knowledgeable colleagues who together play a crucial role in enabling Axis hardware products to reach markets globally. The team is the hub that our R&D projects and colleagues worldwide turn to when it comes to certification and regulatory requirements for our hardware products. Here, high competence is combined with a helpful and welcoming atmosphere - we're happy to share our knowledge and enjoy ourselves together along the way. What you'll do here as Regulatory Engineer R&D As a Regulatory Engineer R&D, your main task is to support our R&D projects with knowledge around the certification of our hardware products. The projects teams are responsible for scheduling and coordination, while you act as their regulatory anchor. You help the projects understand the requirement frameworks, provide regulatory support during external testing, and ensure that all documentation is handled correctly for global market access. In this role, you will: Support to R&D projects: Assist the projects with knowledge regarding regulatory requirements according to LVD, EMC, RED and equivalent requirements in other countries. Regulatory support toward test houses: Act as the projects' regulatory support in the dialogue with external test houses. Global Market Access & certification support: Contribute regulatory knowledge for global certifications and handle the documentation required for international market access. Global support within Axis: Answer questions from Axis' global organization regarding products' certification status and regulatory conditions in different markets. Administration: Ensure that the project's regulatory deliverables (test reports, certificates, Declaration of Conformity) are uploaded to the correct databases and that all documentation is complete ahead of launch. Who we are looking for We're looking for a thorough and structured team player who thrives in a supportive role and is motivated by making others successful. You have an eye for detail and find satisfaction in making sure the documentation is complete and in the right place - even when supporting several projects at the same time. You are analytical, enjoy digging deep into directives and standards, and find it easy to collaborate with colleagues around the world. We'd love to hear that you have/are: Good knowledge of regulations such as LVD, EMC and RED, as well as equivalent global requirements Experienced within the area of regulatory compliance and certification A strong communicator in English, both spoken and written, as you support the global organization and review international documentation Bonus points for (but not required): Experience of or familiarity with the certification of products with Bluetooth. What Axis has to offer We are a world leader in network video, where cutting-edge technology meets global impact. Here, you'll contribute to meaningful projects that shape the future of security and surveillance - developing solutions used worldwide. As a fast-growing company, we offer exciting career opportunities. You'll grow professionally through continuous learning, supported by a collaborative team that values creativity, innovation, and work-life balance. Our Lund HQ Campus, including the impressive Grenden building, offers a dynamic environment with spaces crafted to encourage collaboration, whether through informal "fika" chats, formal meetings, or after-hours activities. Check it out: Axis HQ Your well-being matters to us. We offer a range of benefits, including a company bonus, Friday cake, wellness allowance, health insurance - and even your own Axis bicycle. To learn more about Axis, our innovative products, solutions, and vibrant company culture, explore: Life at Axis blog Engineering at Axis blog Innovation at Axis Ready to Act? Axis is a company realizing the benefits of a diverse workforce. We know that diversity in groups creates a better working environment and promotes creativity, something that is fundamental for our success. We welcome all applications. We go through applications continuously so don't wait - send in your application today! Vacation is important! At Axis we value work-life balance and that means that during summer many of us are on a well-deserved vacation. During this period of time, you can expect some delay in our response, but we will get back to you as soon as possible! In case of questions, please reach out to Maria Lindblad, Engineering Manager Regulatory at +46 (0) 708 68 12 36 (Not available w. 32)

Company description: Getinge is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We employ more than 10,000 people, and have operations in more than 40 countries. Saving lives is the greatest job in the world. Everything we do, from architectural planning to the equipment, therapies and solutions aim to secure the safest and most reliable care. As a leading medtech company, we focus every talent and resource towards helping our customers save as many lives as possible. Job description:About this opportunity At Getinge, the Infection Control business area plays a critical role in ensuring that our products meet global regulatory requirements and continue to support healthcare providers in delivering safe and effective patient care. The Regulatory Affairs function works closely with Quality, R&D, Operations, and global stakeholders to ensure compliance throughout the product lifecycle. As RA Manager Infection Control, you will be part of the Quality compliance, Regulatory & Medical organization. You will collaborate extensively across functions and sites within Infection control business area, as well as with global Regulatory Affairs teams and external regulatory bodies. The role offers a unique opportunity to influence regulatory strategy, strengthen cross-site collaboration, and drive regulatory excellence within a highly regulated MedTech environment. In this role, your primary responsibility will be to lead and drive regulatory affairs activities across Infection Control sites, providing strategic direction, ensuring regulatory compliance, and enhancing cross-site collaboration and efficiency.   What you will do As RA Manager Infection Control, you will lead regulatory activities supporting both business objectives and compliance requirements. You will act as a key regulatory expert and partner across the organization. Key responsibilities include: Develop and implement regulatory strategies to ensure products comply with applicable regulations and standards. Lead and support regulatory submissions and approvals, including CE marking, 510(k) submissions, and other market authorization activities. Act as the primary contact for notified bodies during technical documentation assessments and regulatory reviews. Review and approve technical files, regulatory documentation, labeling, packaging, and product claims. Drive regulatory intelligence activities, provide training, manage regulatory risks, and support audits, inspections, and non-compliance investigations. The preferred location for this role is Sweden. However, for the right candidate, we are open to a remote and/or hybrid working arrangement. No regular travel is required for this position.   You will bring To be successful in this position, we believe you have the following qualifications: Bachelor’s or master’s degree in quality management, Life Science, Industrial Technology, or a related field. At least 3 years of experience in Regulatory Affairs or a related function within a regulated industry. Previous leadership experience (minimum 1 year) with the ability to lead projects and cross-functional teams. Strong knowledge of regulatory compliance, risk assessment, gap analysis, and compliance auditing. Experience working with regulatory databases and advanced Microsoft Office skills. Experience supporting internal and external audits. Meritorious experience includes knowledge of regulatory frameworks and standards such as ISO 13485, ISO 14971, MDR, MDD, MDSAP, and ISO 14001. In addition to your technical expertise, we highly value your personality. We are looking for someone who combines strong analytical thinking with excellent written communication skills and can translate complex regulatory requirements into clear guidance for non-technical stakeholders. You have the ability to build relationships, influence stakeholders, and lead regulatory initiatives across multiple functions and locations. We believe you have a passion for continuous learning and an eagerness to stay up to date with evolving global regulatory requirements, standards, and best practices within the MedTech industry. At Getinge we see ourselves as proactive and self-driven in learning and contributing to the continued development of our products and our organization's capabilities. We are Team Players, Forward Thinkers and Game Changers. We think you will thrive in a high-expectation environment and have an interest in our products.   Why join Getinge Getinge offers a job in a safe and informal work environment, where we appreciate close team collaboration. We keep an open dialogue between leaders and employees, as well as between teams. We are focused on developing people, and together we will create a plan for learning and competence development when you start your career with us. We offer a competitive compensation and benefits package, including wellness allowances, generous family benefits and joint company activities. Everything to ensure we support your well-being and goals. Application Applications will be reviewed continually, and we therefore recommend sending us your application as soon as possible, but no later than 16th August. We kindly ask you to submit your application in our recruitment system by clicking the “apply now” button. Due to GDPR regulations we do not accept applications via e-mail. If you have any questions regarding the role, please contact responsible recruiter Emma Paulsson at email: emma.paulsson@getinge.com We look forward to receiving your application. We hope you will join us on our journey to become the world's most desired MedTech company.

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.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs. Essential Functions: •    Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value. •    Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture. •    Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders. •    Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects. •    Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution. •    Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables. •    Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution. •    Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes. •    Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate. •    Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs. •    Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions. •    Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization. •    Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements. •    Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives. •    Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function. •    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision. Requirements: Education Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.  Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education. Experience •    Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.  •    Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs) •    Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval) •    Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations •    Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations •    Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D. Technical Skills •    Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management •    Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations •    Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS) •    Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions •    Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness •    Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance •    Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously. •    Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making. •    Strong proficiency MS Office Suite. Working Conditions: Requires up to domestic and international travel. The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

ABOUT US Legora is redefining how legal work gets done. Not built for lawyers, built with them. We work alongside the world’s best legal teams, who expect excellence, precision, and speed, and we hold ourselves to the same bar. Our AI-native workspace lets legal professionals move faster, think more clearly, and operate with sharper precision. By analysing thousands of documents in minutes and powering end-to-end workflows, we cut through complexity, teams can focus on what matters: judgment, strategy, and outcomes. 1,000+ customers across 50+ countries trust us, including Cleary Gottlieb, Goodwin, Linklaters, White & Case, Dentons, and Barclays. We’ve scaled to $100M+ in ARR, with teams across Europe, North America and APAC, and continue to expand through acquisitions including Qura, Walter AI and Graceview. We partner with world-class performers: including Aaron Judge and the New York Yankees, Ludvig Åberg (and his caddie), and campaigns featuring Jude Law. Joining Legora means three things. * We lean in: ownership over titles, outcomes over intentions. * We fight for excellence: high standards, direct, ego-free feedback. * We grow together: as a team and with our customers. Mission before ego. Everyone contributes. No one coasts. If you’re driven by impact, pace, and raising the bar. This is the place. The role As Regulatory & Compliance Counsel at Legora, you will be central to our legal technology innovation, ensuring regulatory compliance, managing legal risks, and supporting business operations across all teams. As part of the legal team, you will provide compliance guidance to commercial and product teams on matters ranging from data privacy to AI governance. This is a high-trust, high-responsibility role with clear business impact, requiring you to operate with autonomy, sound judgment, and precise execution. You will serve as a strategic partner to product development, InfoSec, and commercial teams, leveraging your legal expertise to identify solutions and drive innovation in our mission to transform legal work globally. What you will be doing: * Provide compliance oversight and guidance to senior stakeholders across operational, commercial and product teams on regulatory matters, risk assessment, and compliance frameworks for new services, processes, contracts, partnerships, and supply chains. * Review and provide compliance input on commercial contracts, ensuring adherence to regulatory requirements and company policies. * Conduct compliance assessments of product designs, data flows, and operational processes, identifying regulatory risks and developing risk mitigation strategies. * Contribute to building legal infrastructure: templates, playbooks, and internal tooling, including how we use Legora to operationalize legal work and collaborate across teams. * Develop and maintain privacy compliance programs, conduct data protection impact assessments, and ensure ongoing compliance with applicable data protection regulations; and * Establish efficient and scalable compliance frameworks and monitoring systems, developing compliance policies and guidelines that enable teams to proactively integrate regulatory requirements and compliance controls into products and processes. Who you are: * Law degree (LL.M. or equivalent) from Sweden, the UK, or an EU-jurisdiction, qualified to practice in that country. * Proficiency in spoken and written English. Additional language skills are meritorious. * 4+ years of experience at a top-tier law firm and/or as in-house counsel. * Proven expertise advising on GDPR, CCPA, and cross-border privacy compliance. * Familiarity with ISO standards and global compliance frameworks (e.g. AICPA SOC). * Strong experience negotiating B2B SaaS agreements and supporting commercial teams. You’re an excellent negotiator. * Strong legal judgment and confidence in making decisions independently * Highly organised, responsive, and solutions-oriented * Comfortable working across time zones in a global environment, and owning your priorities * Your focus is on achieving meaningful business outcomes, translating into actionable advice delivered clearly and comprehensively. * You thrive in a fast-paced, dynamic entrepreneurial environment and rapidly evolving business setting. You take initiative and are committed to delivering high-quality results. * You are excited about the potential of technology to transform the legal industry. You have a keen interest in AI and legal tech, and you are eager to learn and apply thesetools in real-world settings Legora is an Equal Opportunity Employer At Legora, we believe great teams are built on diversity of thought and experience. We’re proud to be an equal opportunity employer and committed to creating an inclusive, high-performance culture where everyone can do their best work. We welcome people of all backgrounds and don’t discriminate based on race, color, religion, national origin, gender, gender identity or expression, sexual orientation, age, disability, veteran status, or any other characteristic protected by law.

TL;DR We’re looking for a Compliance Engineer who can turn regulatory requirements and security/privacy requirements into scalable engineering solutions. Why Lovable? Lovable lets anyone and everyone build software with any language. From solopreneurs to Fortune 100 teams, millions of people use Lovable to transform raw ideas into real products - fast. We are at the forefront of a foundational shift in software creation, which means you have an unprecedented opportunity to change the way the digital world works. Over 2 million people in 200+ countries already use Lovable to launch businesses, automate work, and bring their ideas to life. And we're just getting started. We're a small, talent-dense team building a generation-defining company from Stockholm. We value extreme ownership, high velocity, and low-ego collaboration. We seek out people who care deeply, ship fast, and are eager to make a dent in the world. What We're Looking For An engineer who has built compliance controls from the ground up. Experience with SOC 2, ISO 27001, GDPR, or similar frameworks. Strong architectural understanding and hands-on experience of common cloud infrastructures. Ability to automate compliance controls using code, scripts, or infrastructure tooling. A collaborative mindset - comfortable working with engineering teams and non-technical stakeholders like legal and marketing alike. What You'll Do In one sentence: Design compliance-by-design systems, automate controls and monitoring, and work cross-functionally to turn regulatory and business requirements into scalable technical solutions for secure data, privacy, and responsible AI. Design and implement compliance-by-design systems across our infrastructure that people actually want to use. Automate compliance controls and monitoring using modern tooling. Work closely with engineering teams to ensure systems meet SOC 2, ISO 27001, GDPR, and emerging AI regulations. Partner with sales, product, platform, and legal teams to translate requirements and needs into technical implementations. Help shape the architecture around data handling, privacy, and responsible AI. Our tech stack We're building with tools that both humans and AI love: Frontend: React Backend: Golang and Rust Cloud: Cloudflare, GCP, AWS, Many LLM providers DevOps & Tooling: Github Actions, Grafana, OTEL, infra-as-code (Terraform) And always on the lookout for what's next! About Your Application Please submit your application in English. It's our company language, so you'll be speaking lots of it if you join. We treat all candidates equally - if you're interested, please apply through our careers portal.

I rollen Service Sales Specialist är du en del av vårt internationella Grid Automation Service Sales Team. Vi erbjuder servicelösningar för stationsautomationssystem, kontroll och skydd, cybersäkerhet, kommunikation och fjärrstyrningsteknik. Du kommer till ett team där dina kollegor är erfarna och motiverade samt arbetar utifrån ett kund- och servicefokuserat arbetssätt. Vår ambition är att leverera service av högsta kvalitet, med lösningar som är anpassade efter kundernas behov. I denna roll ansvarar du för serviceanbud från den initiala kundförfrågan till kontraktsskrivning och överlämning till projektavdelningen. Att utveckla försäljningsplaner för att säkerställa tillväxt inom service, bygga långsiktiga kundrelationer, driva hög kundnöjdhet samt säkerställa att specifika kundbehov och frågor hanteras på rätt sätt, är avgörande framgångsfaktorer för denna roll. Tjänsten är baserad i Västerås, Sverige. Det finns möjlighet till hybridarbete om du bor inom pendlingsavstånd till kontoret. Du är beredd att resa frekvent inom Sverige för att träffa dina kunder. Dina ansvarsområden Implementera strategin för serviceförsäljning och tillväxtplaner, och engagerar dig i den installerade basen (IB) för att främja uppgraderingar och mervärdeslösningar. Använda IB-data för att identifiera och utveckla försäljningsmöjligheter för serviceprodukter och lösningar, med fokus på hela Hitachi Energys serviceportfölj. Du genomför säljsamtal, gör sitebesök hos kunder, genererar leads och utvecklar nya marknadsmöjligheter baserat på marknadstrender. Du etablerar långsiktiga kundrelationer, förstår deras krav och regelverk, visar teknisk kompetens och säkerställer kundnöjdhet. Du säljer serviceproduktportföljen, övervakar försäljningsförslag och anbud, förbereder serviceerbjudanden, kommunicerar kontraktsdetaljer och hanterar den administrativa försäljningsprocessen. Du agerar som marknadsförare och säljare under marknadsaktiviteter, och finner kundbehov till relevanta serviceerbjudanden och lösningar. Du bidrar till riskbedömningar, registrerar information i SFDC, säkerställer teknisk tillförlitlighet, säkerhet och kostnadseffektiva lösningar, samt följer hälso- och säkerhetsdirektiv. Du ger teknisk vägledning för serviceförsäljningsutbildning till mindre erfarna medarbetare och stödjer ledningen med nyckeldata och insikter om marknader och effektiva försäljningstaktiker. Din bakgrund Du har en kandidatexamen eller högre inom relevant område, exempelvis elkraft. Du har minst 5 års erfarenhet av försäljning, försäljningsstöd och/eller service av elkraftsystem/lösningar. Om du har erfarenhet av att arbeta med utrustning för elstationer (t.ex. IED, RTU, SCADA, kommunikation etc.) samt aktuell teknisk försäljning och/eller kundnära erfarenhet av att presentera lösningar för elstationer, är detta starkt meriterande. Du förväntas vara bekant med drift- och underhållspraxis för elstationsutrustning samt konstruktion av elstationer. Det är meriterande om du har erfarenhet av att förhandla långsiktiga serviceavtal för elstationer, eller andra likvärdiga avtal. Om du har kännedom av Hitachi Energys produkter och tjänster inom elkraft är detta meriterande. Flytande svenska och engelska, både i tal och skrift, är ett krav. Vad vi erbjuder Kopplat till rollen finns tjänstebil som alternativ Kollektivavtal Flexibla arbetstider och möjlighet till att arbeta på distans vissa dagar i veckan Företagshälsovård och frisvårdsbidrag Fantastiska karriärsmöjligheter inom Hitachi Energy både inom Sverige och globalt Utbildningar och stöd för din utveckling ​ Kollegial mångfald med över 70+ nationaliteter som arbetar i Sverige Tilläggsersättning för föräldraledighet Förmånsportal för alla medarbetare med över tusentals rabatter och förmåner Mer information Vi är nyfikna på att lära känna dig och vad du kan bidra med. Omfamna mångfald och innovation – bli en del av vårt team på Hitachi Energy! Urval sker löpande och annonsen kan komma att tas ned med kort varsel, så vänta inte – ansök redan idag! Rekryterande chef, Mohamed Hussein, mohamed.hussien@hitachienergy.com, svarar på dina frågor om tjänsten. Fackliga representanter – Sveriges Ingenjörer: Jan Skogeby +46 738 16 42; Ledarna: Frank Hollstedt, +46 107-38 70 43; Unionen: Karin Ulvemark, +46 107-38 51 42. Alla övriga frågor kan riktas till rekryterare Christian Falevik, christian.falevik@hitachienergy.com.

Din nya roll  Vi söker en certifierad Tullspecialist / Customs Specialist till vår kund i Göteborg – ett internationellt bolag inom fordonsutveckling med global verksamhet och högt tempo. I rollen blir du en nyckelperson inom Test Vehicles & Logistics, där du säkerställer ett smidigt och regelrätt flöde av testfordon och komponenter mellan Europa, Kina och andra globala marknader. Du arbetar nära logistik, inköp, ekonomi, juridik och externa partners för att möjliggöra effektiva import- och exportprocesser i en snabbt växande organisation. Arbetet omfattar bland annat tullklassificering, granskning av dokumentation, uppföljning av regelverk samt intern rådgivning i tullrelaterade frågor. Testverksamheten är huvudsakligen placerad i Göteborg men sträcker sig även till testanläggningar i Sverige, EU, Kina och USA. Bra att känna till Uppdragets omfattning: Heltid, 100% Anställningsform: Tidsbegränsad anställning som konsult via JobBusters. Start: Enligt överenskommelse Slut: 2026-10-31, med möjlighet till förlängning I din ansökan: Säkerställ att det tydligt framgår att du är kvalificerad utefter kundens önskade kvalifikationer. För att bli framgångsrik i denna roll behöver du Akademisk examen inom logistik eller motsvarande Certifierad/licensierad tullspecialist eller tullombud Erfarenhet av tull, internationell logistik, import/export eller spedition Mycket god förmåga att hantera och analysera dokumentation med hög noggrannhet, även under tidspress Flytande kunskaper i svenska och engelska i tal och skrift. Meriterande: Erfarenhet från fordonsindustrin eller en snabbväxande scale-up-miljö Meriterande: Kunskap om kinesisk tulldokumentation och/eller logistikflöden mellan EU och Kina Meriterande: Erfarenhet av affärs- och logistiksystem såsom ERP-system och tullhanteringsplattformar Vi erbjuder Trygg anställning med kollektivavtal, försäkringar och tjänstepension Friskvårdsbidrag samt personalrabatter och erbjudanden via Benifex (ex. inom hälsa, fritid, transport och sjukvård) Flexpension och tillgång till Lifeplan pensionstjänst Extra ersättning vid föräldraledighet Företagshälsovård Långsiktiga uppdrag och personlig kontakt med din konsultchef Möjlighet att bygga värdefull erfarenhet, nätverk och framtida utveckling Välkommen med din ansökan Vi går igenom ansökningarna löpande. Då processerna i konsultvärlden ofta går snabbt kan tjänsten tillsättas innan sista ansökningsdatum – vänta därför inte med att skicka in din ansökan! Du behöver inte skriva ett personligt brev utan i stället ber vi dig svara på urvalsfrågorna i samband med ansökan.

Job Title: UAS Test Engineer Location: Sweden, Lund Employment Type: Full-time, Permanent Employer: Katam Technologies AB About the Role: We are seeking a UAS Test Engineer to support the development team with general UAS system tests. In this role, you will be responsible for ensuring system performance meets defined requirements. The position also includes close collaboration with our customers in terms of product demonstrations and education, including development of technical training and documentation materials. This role requires a disciplined engineering mindset, strong analytical capabilities, and the ability to communicate with our customers. Key Responsibilities: • Verification & Validation: Develop and execute test plans, perform system-level verification, analyze results, and ensure compliance with safety, performance, and regulatory requirements. • Simulation & Field Testing: Use simulation environments and real-world flight tests to evaluate system behavior, identify issues, and drive improvements. • System integration support: Support customers to integrate Katam products and services into their own processes and environments. • Educational Leadership: Develop training materials, workshops, and documentation for external partners and customers. Deliver hands-on training sessions on and platform operation. • Cross-Functional Collaboration: Work closely with internal teams to ensure seamless system performance. Qualifications & Experience: • A degree in engineering or at least 4 years’ experience in related field. • At least 5 years of structural test&verification methodology • Long documented experience from advanced UAV operation (>10 years). • Mandatory with at least Specific Category with more than 1000 documented flight hours • Mandatory experience from BVLOS, mapping, multi copter, fixed wing, VTOL and FPV • Mandatory experience from DJI UAV eco-system • Experience in UAV communication protocols and sensor integration. • Strong communication skills and a genuine interest in teaching, mentoring, and knowledge-sharing. • Ability to thrive in a fast-moving environment where autonomy and initiative are valued. To Apply: Please submit your CV and a cover letter detailing your field experience and specific expertise with digital forest inventory tools. About Katam: Katam is a green tech startup founded in 2016 in Lund. They provide the forest sector with data to support operational as well as long-term strategic decisions. By using Computer vision, Artificial intelligence, patented algorithms and Katam’s forestry expertise, forest data is transformed into valuable decision-making facts for their customers around the world. More precise forest management will increase wood volume growth and production yield. These are key components for reducing CO2 net emission and at same time driving business for the global forest industry. The team works from the office in Lund, where around 20 people are currently based. In addition to the main office in Sweden, Katam also has a growing presence internationally, with local offices both in Brazil and Indonesia.

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry. Assignment Description We are looking for an OpenShift/Azure Red Hat OpenShift (ARO) Consultant What You Will Work On Implement, configure, and optimize Azure Red Hat OpenShift (ARO) environments. Support the development and continuous improvement of the OpenShift platform. Monitor platform capacity, performance, and resource utilization. Implement scaling strategies and automate platform operations where appropriate. Collaborate with internal teams to deploy and maintain OpenShift in SDDC and Azure environments. Support application onboarding, testing, and migration to the ARO platform. Configure networking, connectivity, and platform integrations with existing enterprise systems. Implement platform security controls and ensure compliance with regulatory requirements. Develop and maintain platform documentation, configurations, operational procedures, and best practices. Provide technical guidance, knowledge transfer, and training to internal teams. Troubleshoot platform-related issues and support ongoing operational improvements. Work closely with infrastructure, security, DevOps, and application development teams. What You Bring Strong experience with OpenShift and Azure Red Hat OpenShift (ARO). Experience designing, implementing, and managing container platform environments. Strong knowledge of Kubernetes and container orchestration technologies. Experience working with Azure cloud services and hybrid cloud environments. Experience with Software-Defined Data Center (SDDC) environments is an advantage. Knowledge of platform performance tuning, capacity planning, and resource optimization. Experience implementing automation for platform management and operations. Strong understanding of networking, connectivity, and security within container platforms. Experience supporting application deployment and migration to OpenShift platforms. Knowledge of platform security, governance, and regulatory compliance. Experience creating technical documentation, operational procedures, and platform guidelines. Strong troubleshooting and problem-solving skills. Experience collaborating with infrastructure, DevOps, security, and development teams. Excellent communication skills and ability to provide technical guidance and knowledge transfer.

Are you passionate about quality, contamination control, and medical device manufacturing? We are looking for a Cleanliness & Sterility Assurance Engineer to join our team and support the cleanliness and sterility assurance of dental implant products manufactured at our sites in Karlskoga, Sweden, and Yorba Linda, USA. In this role, you will play a key part in ensuring compliance with regulatory requirements and industry standards while contributing to the safety and quality of products that improve patients' lives worldwide. Key Responsibilities As a Cleanliness & Sterility Assurance Engineer, you will: Define validation studies related to microbiological, physical, and chemical cleanliness for new equipment and equipment modifications. Lead and execute cleanliness process validations for new and updated manufacturing equipment. Develop and implement cleanliness monitoring activities in collaboration with the Contamination Control Manager. Maintain and update contact material mapping documentation. Establish and maintain procedures, templates, and best practices to ensure standardized cleanliness validation and monitoring processes. Support biological and microbiological safety strategies across the organization. Coordinate and manage external testing activities with approved laboratories and vendors when required. Collaborate with cross-functional teams to support continuous improvement and regulatory compliance initiatives. Qualifications and Experience To succeed in this role, you should have: A Master's degree (MSc) or equivalent in Biotechnology, Biomedical Engineering, Microbiology, Toxicology, Biology, Chemistry, or another relevant scientific discipline. At least 5 years of experience within the Medical Device industry or a comparable regulated environment. Strong knowledge of contamination control, cleanliness assurance, and applicable regulatory standards, or the ability to quickly develop expertise and work independently with limited supervision. Experience with relevant standards such as ISO 13485 and ISO 11137-1 & 2. A solid understanding of manufacturing processes and process validation methodologies. Strong expertise in statistical analysis and interpretation of technical data. Excellent communication skills, both written and verbal. Fluency in English. Swedish language skills are considered an advantage. A structured, analytical, and problem-solving mindset.

Do you have a passion for Lending or Trading & Capital Markets processes? If you are interested to work with a broad range of business areas, from large corporates to private customers, this position may be the right one for you. Group Internal Audit is playing a crucial role not only as a 3rd line of defence control function, but also as a trusted advisor for the business. We are now looking for a colleague who can contribute and take lead in audits relating to Swedbank’s Swedish Business Areas. In Swedbank you have the opportunity to: • Evaluate Lending and Trading & Capital Markets processes including compliance with regulatory requirements and internal policies. • Identify potential risks associated with Lending and Trading & Capital Markets and provide recommendations to mitigate such risks. Collaborate with stakeholders across various departments to ensure thorough understanding and transparent communication regarding audit findings. • Work cross-functional with other GIA teams with complementary competences and skills to cover the key risks for Swedbank’s Swedish Business Areas Swedish Banking and Corporates & Institutions. • Be involved in audits of Swedbank’s international branches in Norway, Finland, New York and Shanghai as well as the subsidiaries Swedbank Hypotek, Stabelo and Entercard. • Provide input to annual and continuous risk assessments, planning and quarterly reporting. • Through audit engagements, assist senior management in identifying sustainable improvements towards transforming the Bank and helping it to reach its strategic goals. • Continuously develop through structured internal and external education as well as collaboration with GIA colleagues with different competences and skills. What is needed in this role: • Demonstrated experience (minimum 5 years) from working in similar positions in the financial industry, preferably from a larger bank, external audit firm or supervisory authority. • In-depth understanding of Lending and/or Trading & Capital Markets processes and knowledge of external regulations in these areas. • Excellent written and verbal communication skills; ability to present complex information clearly to non-expert stakeholders. • Strong interpersonal skills; being curious, courageous, maintaining high integrity as well as an adaptable mindset. • Good analytical skills, a strategic mindset with strong business acumen. • Skills in project management with the ability to handle tight deadlines. • Master's or Bachelor’s degree in Business Administration and/or Economics or a related field. • Proficiency in the Swedish language. • Experience from using AI and data analytics tools such as Power BI is an advantage. • Certification such as CIA, CISA, CFSA and SwedSec is a merit. With us, you can experience: Personal and professional growth through self-leadership and continuous development. Meaningful work that positively impacts our workplace, our customers, and society. An open and collaborative culture that encourages cross-functional teamwork and provides networking opportunities. A supportive and inclusive environment that promotes a balanced and sustainable work-life, with flexible working conditions when suitable for the role. Benefits such as our share based reward program Eken, company pension plan, employee offer for banking products, health insurance. "Join our team and... be a part of a department with experienced colleagues with deep knowledge of different aspects of the Swedbank. Group Internal Audit (GIA) is a valuable tool for the Board of Directors and the Group Executive Committee in the fulfilment of strategy and goals, but also when it comes to strengthen the internal control, risk management and organisational governance. GIA consists of ~75 employees in all our home markets Sweden, Estonia, Latvia and Lithuania. Our responsibilities cover all areas of Swedbank including audit activities in our branches in New York, Shanghai, Norway, and Finland. Our mission is to enhance and protect organisational value by providing risk-based and objective assurance, advice, insight and foresight. Our vision is to be a trusted advisor and to be the most attractive audit function for people to grow. We contribute to the Group’s achievement of the Strategic Direction by evaluating and improving the effectiveness of the organisation’s governance, risk management and internal control and in doing so promoting a sound and sustainable control environment and risk culture within the Group.” Lars Wålinder, your future manager We look forward to receiving your application by 14.08.2026.  Location: Sundbyberg Recruiting manager:  Lars Wålinder We may begin the selection during the application period, so we welcome your application as soon as possible. We have made our choice regarding recruitment media and therefore kindly decline contact with ad sellers or sellers of other recruitment services. We would like to let you know that a background check and a drug test may be a part of the process for this role. (Applies to recruitment in Sweden) Swedbank does not discriminate anybody based on gender, age, sexual orientation or sexual identity, ethnicity, religion or disability – everybody is welcome. #LI-Hybrid #LI-SW1

Do you want to help ensure the safety and compliance of innovative energy solutions? At NIBE, we develop market-leading products that contribute to a more sustainable future. We are now looking for a Safety Compliance Engineer to Markaryd who is passionate about product safety, regulatory compliance, and technical excellence. In this role, you will work closely with colleagues across development, testing, and certification to ensure our products meet applicable legal and safety requirements throughout their lifecycle. About the Role As a Safety Compliance Engineer, you will play a key role in ensuring that NIBE products comply with relevant legislation, harmonised standards, and internal compliance requirements. You will coordinate testing activities, maintain technical documentation, support certification processes, and contribute to standardisation work at both national and international levels. This is a collaborative role where you will work closely with engineering, product development, testing teams, and external certification bodies to identify, assess, and resolve compliance-related matters. Location: Markaryd Your Responsibilities Ensure compliance with applicable safety legislation, including LVD, RED, and MD, as well as safety requirements within the IEC 60335 standards relevant to heat pumps and related accessories. Plan, conduct, and follow up compliance testing and technical evaluations, both in-house and in collaboration with external laboratories. Coordinate certification activities and manage relationships with testing and certification partners. Support engineering and product development teams in identifying and resolving compliance and safety-related challenges throughout the product lifecycle. Develop, maintain, and update technical compliance documentation in accordance with regulatory and internal requirements. Monitor developments in legislation, standards, and regulatory requirements affecting NIBE products. Provide guidance, training, and support to colleagues regarding compliance processes and product safety requirements. Your Profile We are looking for a structured and proactive professional with a genuine interest in product safety and regulatory compliance. You are comfortable working independently while also collaborating effectively across different functions and stakeholders. To succeed in this role, you likely have: A relevant degree or professional experience within electrical engineering, mechanical engineering, product safety, compliance engineering, or a related technical field. Knowledge of regulatory frameworks such as LVD, RED, Machinery Directive, or similar product compliance requirements. Experience working with CE marking and European regulatory requirements. Strong analytical and problem-solving skills. Excellent communication skills and the ability to build strong relationships with both internal and external stakeholders. Fluency in spoken and written English. Why Join NIBE? NIBE is one of Europe's leading manufacturers of sustainable energy solutions. We combine innovation, technical expertise, and a strong commitment to quality to create products that make a real difference for our customers and for the environment. At NIBE, you will have the opportunity to work in an international environment where your expertise contributes directly to the development of safe, reliable, and sustainable products for the future. More about us We exist to provide the world with better energy solutions. Since 1952, we have worked with passion and determination to develop new methods for improved energy efficiency. In doing so, we play an important role in the global transition to a more sustainable society. Our products are built on the finest Swedish engineering expertise. We have a strong market position and are making significant investments for the future. Our corporate culture is characterized by a family-oriented and entrepreneurial spirit, built on a long tradition and rich history where simplicity, humility, and reliability are key values. We take a long-term view of your employment and offer a workplace with excellent career opportunities. Together, we ensure that you can make the most of your talent, creativity, and expertise. NIBE in numbers NIBE AB is a modern and successful industrial company with annual revenues of over SEK 5 billion and more than 1,250 employees in Markaryd. NIBE is one of the market leaders in Europe, offering one of the industry’s broadest product ranges, including heat pumps, water heaters, solar panels, biofuel products, ventilation solutions, district heating equipment and more. NIBE AB is part of the publicly listed NIBE Industrier Group, which has annual revenues of approximately SEK 40 billion and more than 21,000 employees across over 30 countries. Application Does this sound like the right opportunity for you? Apply via our website under Available positions at NIBE. We review applications on an ongoing basis, so we encourage you to apply as soon as possible. The final application date is August 9. Please note that due to the holiday period (weeks 28–31), there will be a temporary pause in the recruitment process. The selection process will resume at the beginning of August. Questions? If you have any questions or would like to know more, please feel free to contact one of the persons listed below. Please note that due to the holiday period (weeks 28–31), there will be a temporary pause in the recruitment process. The selection process will resume at the beginning of August. Welcome with your application!

The role We call ourselves a 60-year-old startup. Decades of scientific heritage, paired with the speed, ambition and hands-on energy of a company being built from the ground up. Right now, we're scaling manufacturing fast, and that means the way we assure sterility needs to scale with it. We're looking for a Sterility Assurance Lead who wants to own that agenda from day one, not just maintain a system, but shape how sterility assurance grows alongside the site. You will own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Key Responsibilities Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards. Oversee environmental monitoring, cleanroom qualification, and aseptic practices. Review sterilization validations and lead media fill programs. Drive contamination risk assessments, investigations, and CAPAs. Act as SME during audits and inspections. Provide training and mentorship in sterility assurance best practices. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You're energized rather than unsettled by a fast-scaling environment, you bring a proactive, solution-oriented approach that lets you spot risks early, drive improvements, and push operational excellence forward even as priorities shift. You thrive in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You're confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance, and you see this growth phase as a chance to grow your own scope right along with it. Requirements Bachelor's or Master's degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline. 8–12 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry. Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits. Hands-on experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations. Skills Deep technical expertise in aseptic processing, sterilization technologies (moist heat, dry heat, filtration), and microbial contamination control. Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems. Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA, EMA, PIC/S). Experience performing risk assessments using tools such as FMEA, HACCP, or similar methodologies. Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives. Excellent documentation skills and a structured approach to problem-solving and investigations. Strong communication and collaboration skills with the ability to influence cross-functional teams. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.