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.