Regulatory Affairs

Senior Regulatory Affairs Officer   Location: On-site in Geneva, Switzerland  Join a dynamic team specializing in the design and manufacturing of hyaluronic acid-based dermal fillers. As a Senior Regulatory Affairs Officer, you will be integral to shaping regulatory strategies for our innovative product range, managing regulatory submissions, and ensuring compliance with FDA requirements. You will coordinate responses to FDA inquiries, review product labeling, and participate in audits and inspections.  Key Responsibilities: Develop and implement regulatory strategies within cross-functional teams. Manage regulatory submissions (e.g., IDEs, PMAs) and ensure compliance with FDA requirements. Coordinate responses to FDA inquiries and review product labeling. Participate in audits and inspections to ensure regulatory compliance. Maintain and update regulatory databases and SOPs. Requirements: +6  years of experience in the medical device industry. Proficient in quality standards (ISO 13485) and regulations (21 CFR Part 820, MDR 2017/745). Strong analytical and critical thinking skills. Ability to manage multiple projects and prioritize effectively. Fluent in English and good level of French. Who Are Adaptive Life Science? Here at Adaptive Life Science, we provide specialised recruitment services to the Life Science sector, covering the Medical Device, Diagnostic, and Biotech industries globally. We are connected with the most innovative medical companies in the world, and are ready to support your career development with them.   Why Apply With Us? Our services are 100% free to candidates, and our focus is helping you find your dream job that aligns with your career goals, technical skill set, and culture fit. We offer a range of services, including: Expert advice on your CV and cover letter Guidance on salary expectations Personalized interview preparation Connections to exclusive job opportunities Assistance in negotiating the best possible offers 50% of the CVs we send to clients are accepted Accepted or declined, either way we will provide you with feedback We believe in being your trusted advisor throughout your job search. We will take the stress out of the process by working around your schedule, and with your needs. Who Do Adaptive Work With? We offer a wide portfolio of over 150+ Life Science companies, from start-ups with impressive funding and innovative product development, mid-sized companies investing in R&D, all the way to market leaders with significant global presence. If you are interested in this role, please apply with your CV or contact Dominika Wyrwinska for further details on this opportunity and additional vacancies in the medical device, biotech, and diagnostics industry.   dominika.wyrwinska@adaptivelifescience.com #LI-DW1

Head of Global Regulatory Affairs   Are you an experienced Regulatory Affairs professional who is passionate about utilizing AI to make a global impact in healthcare? Our Berlin-based client, an innovator in AI-driven diagnostic solutions, is currently looking for a Global Head of Regulatory Affairs. This role offers home office flexibility and the chance to lead a global team as they expand into international markets, including the US. You would oversee compliance, lead two employees, coordinate teams in India and Egypt, and support market access initiatives.   Your tasks:  Design and monitor processes according to ISO 13485 Lead the regulatory development of certified, AI-based medical devices Expand their software to new international markets, including the USA Oversee risk management in accordance with ISO 14971 Support the product team throughout the product lifecycle, and liaise with government agencies to uphold safety and effectiveness. Collaborate on data protection and IT security issues. Your Profile Experience with ISO 13485 for medical devices, preferably in SaMD. Knowledge of MDR, IEC 62304, ISO 14971, etc. +5 years of experience in Regulatory Affairs within medical technology Strong sense of responsibility and organization Excellent communication skills in English and German What is offered: A dynamic, results-oriented work environment with flexible office/home options. Opportunities for skill development through conferences, workshops, and seminars. Regular team events to enhance corporate culture and solidarity. If you're ready to pioneer the future of AI in healthcare, apply now! If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com #LI-DW1 #LI-Remote