Regulatory Affairs Officer

Barrington James; Dijon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un Officier en affaires réglementaires pour gérer les soumissions réglementaires et garantir la conformité des dispositifs médicaux. Ce rôle implique de travailler avec des équipes internes et des autorités réglementaires pour assurer le respect des normes et des exigences. Si vous souhaitez contribuer à des technologies médicales de pointe et évoluer dans un environnement dynamique, cette opportunité est faite pour vous.

Prestations

Environnement de travail dynamique

Opportunités de développement de carrière

Qualifications

• 3+ ans d'expérience en affaires réglementaires dans l'industrie des dispositifs médicaux.
• Connaissance approfondie des réglementations des dispositifs médicaux, y compris EU MDR, ISO 13485, FDA.
• Familiarité avec la surveillance post-commercialisation et le reporting de vigilance.

Responsabilités

• Assurer la conformité avec les réglementations des dispositifs médicaux et les normes.
• Préparer et soumettre la documentation technique, les dossiers d'enregistrement et les demandes d'autorisation de mise sur le marché.
• Participer aux activités de surveillance post-commercialisation.

Connaissances

Analyse

Résolution de problèmes

Communication

Organisation

Formation

Master en ingénierie qualité/réglementaire, sciences biomédicales ou domaine connexe

Description du poste

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!