Responsable Affaires réglementaires / Dispositif Médical

About This Opportunity

We are representing a confidential life sciences organization seeking an experienced Regulatory Affairs Manager for Medical Devices to join their team in Dijon, France. This strategic role offers the opportunity to lead regulatory initiatives for medical device development, CE marking activities, and lifecycle management while collaborating with cross-functional teams to ensure the highest standards of quality and compliance.

Responsibilities

• Develop and implement regulatory strategies to support product development, registration, and market access activities
• Prepare, maintain, and update Technical Documentation in accordance with MDR 2017/745 requirements
• Coordinate CE Marking activities for medical devices
• Assess the regulatory impact of product changes throughout the product lifecycle
• Ensure compliance with applicable standards and regulations, including MDR 2017/745, ISO 13485, and ISO 14971
• Support Post-Market Surveillance (PMS), Vigilance, and Post-Market Clinical Follow-up (PMCF) activities
• Participate in internal and external audits, inspections, and regulatory assessments
• Interface with Competent Authorities and external regulatory partners
• Monitor and interpret regulatory developments and communicate potential impacts to stakeholders
• Collaborate closely with Quality Assurance, R&D, Clinical, Manufacturing, and Marketing teams
• Provide regulatory guidance and training to cross-functional teams

What We're Looking For

• Master's degree in life sciences, pharmacy, chemistry, or a related field
• At least 10 years of experience in QARA (Quality Assurance & Regulatory Affairs) within the medical device field
• Significant experience with Class II medical devices
• Proven experience in Regulatory Affairs within the pharmaceutical, biotech, or medical device industry
• Involvement in global submissions and lifecycle management activities
• Experience in cross-functional collaboration or project coordination is a plus
• Strong knowledge of regulatory requirements and submission processes, as well as post-approval activities
• Good understanding of quality systems and product development
• Excellent communication, stakeholder management, and organizational skills
• Fluent in English and French (written and spoken)

How We Work With You

When you apply through Get A Job.ai, our talent team will review your qualifications and conduct an initial screening. If your background aligns with our client's needs, we will submit your profile for their consideration and coordinate all subsequent interview stages. Please do not contact the client directly—all communication should flow through Get A Job.ai to ensure a smooth process for everyone involved.

Pay

Compensation details will be discussed during the screening process based on your experience and qualifications.

Equal Opportunity: Get A Job.ai is committed to creating an inclusive recruitment process. We welcome applications from all qualified candidates regardless of background, identity, or circumstance.