Regulatory Affairs konsult

Company Description Vattenfall is one of Europe’s largest producers and retailers of electricity and heat. Our main markets are Sweden, Germany, the Netherlands, Denmark, and the UK. The Vattenfall Group has approximately 21 000 employees. We have been electrifying industries, powering homes and transforming life through innovation for more than 100 years. Job Description The Customers Nordic business area develops and sells electricity and energy solutions to consumers and businesses in Sweden, Finland, Denmark, and Norway - currently serving approximately 1.1 million customers. Our department, Strategy & Development, plays a key role within the Nordic organization. We are responsible for three main areas: Strategic development: We continuously develop Customers Nordic’s overall strategy and ensure that operations deliver according to the strategic plan. Energy advisory and climate coaching: We support our customers with advice on energy and climate-related issues and how they can reduce their climate impact. Regulatory monitoring and development: We are now looking for a new colleague for the role of Senior Regulatory Expert. As a Senior Regulatory Expert, you will have the opportunity to directly influence both our business and our ambition to enable a fossil-free society. You will be part of an experienced and highly competent team with strong team spirit and will have close contact with the leadership across Customers Nordic. You will also have significant opportunities to influence how we develop our operations going forward. Strategy & Development is located at Vattenfall’s headquarters in Solna. About the role As a Senior Regulatory Expert, you will support Customers Nordic’s work with regulatory matters. This role acts as a bridge between Vattenfall’s staff function Public & Regulatory Affairs (PRA) and our sales organization, where you will contribute to influencing, interpreting, and communicating regulatory changes internally with the aim of turning them into competitive advantages. Your main responsibilities will include: Monitoring and identifying energy market related regulatory proposals and analyzing how they impact our operations. Developing positions and preparing materials to influence regulatory initiatives. Coordinating and drafting responses to consultations. Participating in external forums with authorities and industry organizations. You will also support the business units within Customers Nordic in matters related to regulations. This includes: Assisting in the planning and implementation of new and updated regulations. Providing ongoing advice regarding regulatory matters. Identifying business opportunities that may arise in connection with new or amended regulations. Qualifications We are looking for someone who has: A university degree in law, engineering, economics, or another relevant field Knowledge of the Nordic electricity market, particularly regarding retail electricity and balancing responsibilities At least 5 years of experience working with electricity market-related issues Experience working with regulatory matters Fluency in Finnish or Swedish, and English is required. Proficiency in the other language is considered an advantage It is considered an advantage if you also have: Knowledge of regulations related to demand response/flexibility such as NCDR and BSP/BRP As a person You enjoy continuously developing your understanding of the electricity market and its future development, and you strive to stay at the forefront of the development regarding future market changes. This involves both continuously familiarizing yourself with new regulatory initiatives and leading internal working groups to analyze their implications. You are driven, collaborative, and structured. Additional Information Our Offer We offer a challenging and international work environment and the possibility to work with some of the best in the field. You will be working in interdisciplinary teams and you can always count on support from committed colleagues as ‘Ask and Share’ concept is essential for the way we work. We offer attractive employment conditions (smart working, flexible working hours and a good-work-life balance) and opportunities for personal and professional development. Click here for further information. Location Helsinki or Solna For more information about the position you are welcome to contact hiring manager Andreas Sjöblom, andreas.sjoblom@vattenfall.com For more information about the recruitment process you are welcome to contact our recruiter Anna Uppström, anna.uppstroem@vattenfall.com Trade Union representatives in Sweden via Vattenfall´s switchboard +46 8 739 50 00. Patrik Andersson, Akademikerna, Cecilia Bodin, Ledarna, Jan Svensson, SEKO, Simon Salomonsson, Unionen. We welcome your application in English no later than August 9. Due to the summer holidays, we will respond to questions about the position once we are back. The selection process will begin after the application deadline. We kindly request that you do not send applications by any means other than via our website and that you refrain from submitting a cover letter with your application. You apply quickly and easily by answering screening questions and attaching your CV. At Vattenfall, we value being active, positive, open, and safety-conscious. We are looking for employees who share our vision and can contribute to strengthening our corporate culture. We firmly believe that diversity helps build a more profitable and attractive company, and we strive to be good role models when it comes to diversity. Vattenfall actively works to ensure that all employees have the same opportunities and rights regardless of age, ethnic or cultural background, gender identity, religion/belief, sexual orientation, or disability. Read more about how we work with diversity and inclusion here. The security of Vattenfall and its employees is essential. For that reason, a pre-employment screening will be part of your recruitment process. The screening is based on the role you will fulfill within Vattenfall. Working at Vattenfall means working with critical societal infrastructure. Therefore, many of our positions are security-classified, and you may be required to fill a wartime posting. If this position is security-classified, a security clearance will be carried out before employment, in accordance with the Security Protection Act.

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.