Regulatory Affairs Officer

Regulatory Affairs Officer

Dijon, Bourgogne-Franche-Comté, France (Hybrid)

Regulatory Affairs Officer

We are looking for a Regulatory Affairs Officer to join our team and take ownership of regulatory submissions, product compliance, and market approvals. This is a fantastic opportunity to be part of an innovative company that is committed to delivering high-quality medical devices to the market.

As a Regulatory Affairs Officer, you will be responsible for ensuring compliance with medical device regulations and standards. You will work closely with the Quality Assurance & Regulatory Affairs Manager to:

 Regulatory Strategy & Compliance

• Conduct regulatory and normative monitoring for manufactured products and packaging, tracking changes, and assessing their impact.
• Develop and implement regulatory strategies to support product approvals across multiple markets.
• Lead change control projects related to evolving regulatory requirements.
• Support internal audits, non-conformity resolution, and corrective & preventive actions (CAPA).

 Regulatory Submissions & Documentation

• Prepare and submit technical documentation, registration dossiers, and market authorization applications.
• Ensure compliance with EU MDR, ISO 13485, FDA regulations, and other international requirements.
• Maintain and update regulatory declarations and notifications.
• Monitor approval processes and track product registration status.
• Ensure timely renewal of market authorizations to support business continuity.

 Post-Market Surveillance & Continuous Improvement

• Participate in post-market surveillance (PMS/PSUR) activities and ensure compliance with reporting requirements.
• Support customer complaint investigations and risk management processes.
• Oversee the release of finished products as part of the QARA team's business continuity plan.

 Collaboration & Cross-Functional Support

• Work closely with internal teams, including R&D, Quality, and Supply Chain, to ensure regulatory requirements are met.
• Engage with regulatory authorities, notified bodies, suppliers, and external consultants to support compliance efforts.
• Lead and participate in regulatory project meetings and change control initiatives.

Education & Experience:

• Master's degree in Quality/Regulatory Engineering, Biomedical Science, or a related field.
• 3+ years of experience in Regulatory Affairs within the medical device industry.

Technical Skills & Expertise:

• Strong knowledge of medical device regulations, including EU MDR, ISO 13485, FDA 21 CFR 820, and international standards.
• Experience in regulatory submissions, technical file updates, and market approvals.
• Familiarity with post-market surveillance, vigilance reporting, and compliance monitoring.
• Understanding of risk management, CAPA processes, and quality systems.
• Proficiency in problem-solving tools to identify and address regulatory challenges.

Soft Skills & Mindset:

• Strong analytical and problem-solving abilities.
• Excellent communication and interpersonal skills to work with both technical and non-technical stakeholders.
• Highly organized, detail-oriented, and capable of managing multiple projects.
• Ability to adapt to evolving regulatory requirements and work in a fast-paced environment.

Why Join Us?

Work with cutting-edge medical technologies that make a real impact on patient lives.

Grow your career in a supportive and dynamic regulatory environment.

Collaborate with a passionate and driven team in a company that values innovation and compliance.

If you are looking for a role where you can apply your regulatory expertise, work on global submissions, and be part of a forward-thinking company, we would love to hear from you