Director of Quality and Regulatory Affairs

We are seeking an experienced Director of Quality and Regulatory Affairs to support our client in their mission of advancing healthcare through innovative medical technologies. If you have a passion for leading quality and regulatory teams and ensuring the delivery of compliant, high reliability medical devices, this could be your next challenge.

Key Responsibilities

• Manage quality and regulatory teams, fostering collaboration and driving operational excellence.
• Oversee production quality, ensuring compliance with QMS and regulatory requirements.
• Develop and implement a comprehensive QARA strategy aligned with company objectives.
• Drive quality initiatives, including risk management (e.g., pFMEA), supplier quality, and certification efforts (e.g., ISO 13485).
• Ensure regulatory compliance for product development and market access (EU MDR, FDA submissions).
• Collaborate with cross functional teams to support industrialization, manufacturing, and supplier management.
• Define and manage the QARA budget, including coordination with external consultants.
• Inspire and mentor team members, fostering a culture of quality, compliance, and innovation.

Required Skills and Qualifications

• Proven leadership experience in quality and regulatory affairs within the medical device sector.
• Strong expertise in ISO 13485, FDA processes, and regulatory standards (e.g., IEC 62304, IEC 60601, ISO 14971).
• A track record of implementing and managing QMS in regulated environments.
• Experience in managing multidisciplinary teams and budgets.
• Master’s degree in a technical field (e.g., biomedical engineering, physics).
• Fluent in technical English; additional experience with electro medical devices is a plus.

Benefits

• Competitive salary based on experience.
• Opportunities for professional growth in a dynamic and innovative environment.
• Collaborative, high impact work culture.
• Flexibility with hybrid work arrangements across two locations in France.