Regen Lab SA has been dedicated to the production of medical devices dedicated to autologous blood derivatives (PRP) for therapeutics in sports medicine, orthopedic surgery, urology, aesthetic medicine, and wound treatment. To complete our team based in Le Mont-sur-Lausanne, we are looking for a Regulatory Affairs Manager.Your responsibilities- Define and deploy the regulatory strategy for target markets.- Ensure the compliance of medical devices according to applicable regulations (MDR, FDA, ISO standards).- Prepare, maintain, and submit regulatory files.- Interact with competent authorities, notified bodies, and external partners.- Participate in change control activities and regulatory impact assessments.- Collaborate closely with Quality, R&D, Clinical, and Marketing teams.- Ensure proactive regulatory monitoring and support internal teams on regulatory topics.- Manage, support, and develop the Regulatory Affairs team.- Organize priorities, distribute activities, and ensure compliance with regulatory deadlines.- Contribute to the recruitment, integration, and skills development of the team.Your profile- Scientific or engineering degree, ideally supplemented by training in regulatory affairs.- Confirmed experience (minimum 5 years) in regulatory affairs applied to medical devices (class II and III, implantable).- Successful experience in management or team leadership.- Good command of the European MDR regulation and associated quality standards.- Experience with FDA submissions appreciated.- Fluent French and English, written and spoken.- Leadership, rigor, and excellent communication skills.We offer- A dynamic and innovative environment within the MedTech sector.- Projects with high added value.- A position with managerial responsibilities.- A culture oriented towards continuous improvement.- Competitive conditions and development prospects. jid2f62113aen jit0624aen jpiy26aen