Are you a Regulatory Affairs professional in the medical technology field, looking for a new opportunity? Would you like to support the international market access of high-risk, complex medical devices? We're currently supporting a client in the medical device industry who are located in Freiburg and looking to strengthen their team. Key Responsibilities: Prepare and compile regulatory submissions for new medical device registrations and updates to existing products in compliance with regulations Oversee the successful approval of Class III medical devices for the European and US markets (MDR and FDA regulations) Monitor new legislation, policies, standards, and guidelines Perform post-market surveillance and report any adverse events or field safety corrective actions Overseeing engineering changes, product labelling, and promotional materials Requirements: A degree in Biomedical Engineering, Life Sciences, or a related field At least 3-5 years of experience in regulatory affairs/international product approvals Comprehensive understanding of MDR/FDA requirements and associated guidelines Fluency in German and English If you're interested in this position, please apply and/or contact Hollie Dear at Adaptive Life Science for more information.