Requirements: English
Company: Barrington James
Region: Dijon , Bourgogne-Franche-Comt
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 teams 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:
- Masters 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