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