Regulatory Affairs Officer

The Company Our client is a long-established European medical device manufacturer specialising in implants and artificial ligament systems is seeking a Regulatory Affairs Officer to join its expanding Quality & Regulatory Affairs team. Renowned for innovation, precision engineering, and a strong focus on patient outcomes, the company designs and manufactures implantable devices distributed across international markets. The Role Reporting to the Quality & Regulatory Affairs Manager, you will play a central role in ensuring regulatory compliance for a portfolio of implantable devices and associated surgical instrumentation. Your key responsibilities will include: Developing and maintaining regulatory strategies in alignment with EU MDR 2017/745 and related international standards. Preparing, submitting, and maintaining technical documentation for Class IIb/III implantable medical devices. Supporting CE marking renewals, vigilance reporting, and change control management. Conducting ongoing regulatory and normative monitoring, evaluating the impact of updated standards. Contributing to post-market surveillance (PMS/PSUR), complaint handling, and field safety corrective actions. Collaborating with R&D, Quality, and Manufacturing teams to ensure regulatory compliance throughout the product lifecycle. About You You are a proactive, hands-on regulatory affairs professional with experience in the medical device industry and: Proven expertise in EU MDR submissions for Class IIb or Class III implantable devices. Experience with CE marking, technical documentation, and conformity assessments. Strong understanding of ISO 13485, ISO 14971, and risk management for implantable devices. Knowledge of biocompatibility (ISO 10993) and sterilisation standards is highly desirable. Comfortable working in a hands-on, engineering-led environment with cross-functional teams. Fluent in French and proficient in English, both written and verbal. Must be able to work onsite in Dijon, France. What They Offer Opportunity to work with cutting-edge implant technologies and artificial ligament systems. Join a highly specialised, growing medtech manufacturer with international reach. Onsite, collaborative environment fostering close interaction with R&D and production. Competitive salary, stability, and long-term growth within Regulatory & Quality functions. Interested in this position? Apply now! ✉ caustin@barringtonjames.com ☎ 44 (0) 1293 776644

Location: Dijon, FR

Posted Date: 10/30/2025