Regulatory Affairs Officer

Barrington James

  • Côte-d'Or
  • CDI
  • Temps-plein
  • Il y a 2 mois
Job DescriptionRegulatory Affairs OfficerDijon, Bourgogne-Franche-Comté, France (Hybrid)Regulatory Affairs OfficerWe 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!

Barrington James