Spécialiste Affaires Règlementaires

REGULATORY AFFAIRS SPECIALIST – MEDICAL DEVICES Bourgogne-Franche-Comté | On-site THE COMPANY Medical device company operating in a highly regulated environment, developing and commercializing innovative products for international markets. The company is committed to quality, regulatory compliance, and patient safety. THE OPPORTUNITY As a Regulatory Affairs Specialist , you will play a key role in ensuring regulatory compliance of medical devices throughout their lifecycle, from development to market access and post-market activities. You will work closely with Quality, R&D, and cross-functional teams in a regulated MedTech environment. RESPONSIBILITIES Prepare, review, and maintain EU MDR technical documentation (Annex II & III) Ensure compliance with Regulation (EU) 2017/745 (MDR) Participate in CE marking activities and regulatory submissions Support change control and assess regulatory impact of product modifications Interface with Notified Bodies and competent authorities Contribute to post-market activities (PMS, PMCF, vigilance) Participate in regulatory intelligence and monitoring of regulatory changes Collaborate closely with Quality, R&D, Clinical and Industrial teams REQUIRED PROFILE Degree in Life Sciences, Biomedical Engineering, Pharmacy or equivalent 2–5 years of experience in Regulatory Affairs for medical devices Solid knowledge of EU MDR 2017/745 Experience with technical documentation and CE marking Familiarity with ISO 13485 and ISO 14971 Ability to work in a cross-functional and international environment Fluent English (written and spoken); French required WHY JOIN? Join a dynamic MedTech environment with strong regulatory challenges Hands-on regulatory role with real impact on product lifecycle Collaborative culture and close interaction with technical teams Long-term opportunity in a stable and regulated industry