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

• 25 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