Director of Quality and Regulatory

We are seeking an experienced Director of Quality and Regulatory to support our client in their mission to advance medical technology through innovative neurovascular devices. If you have a passion for leading quality and regulatory teams, ensuring compliance with global standards, and driving the development of high-reliability medical devices, this could be your next challenge.

Responsibilities

• Develop, implement, and improve the Quality Management System (QMS) to maintain compliance with ISO 13485, FDA 21 CFR Part 820, and other global regulations.
• Oversee internal and external audits, including interactions with Notified Bodies, the FDA, and PMDA.
• Manage change control processes, ensuring all product and process modifications are well-documented and compliant.
• Drive continuous improvement initiatives, including CAPA processes, non-conformance management, and risk mitigation.
• Lead regulatory strategy development, ensuring alignment with FDA, MDR (EU), PMDA (Japan), and ISO standards.
• Oversee product verification and validation, ensuring product quality exceeds compliance standards.
• Manage regulatory submissions such as De Novo, CE Marking, and Shonin applications.
• Engage with regulatory authorities, leading Q-Sub meetings with the FDA and Notified Bodies.

Requirements

• Degree in medicine, pharmacy, engineering, or a relevant scientific field.
• 5+ years of experience in regulatory affairs and quality management for high-risk (Class III) medical devices.
• Strong experience in regulatory submissions (EU and/or US) and audits with global regulatory bodies.
• Fluent in French and English (written and spoken).
• Strong communication, analytical skills, and a pragmatic approach to problem-solving.
• Ability to work effectively in a multicultural, team-oriented environment.

Benefits

• Permanent contract (cadre status) based in the Île-de-France region.
• Reduction of working time (RTT) for improved work-life balance.
• Comprehensive health insurance and access to an advanced medical support platform.
• Electronic meal vouchers.
• 50% reimbursement of transport costs.

Your consultant.

Taylor Lyons is a Recruitment Consultant at Aspire Life Sciences. He specialises in bridging the gap between talented professionals and leading companies within the Medical Device sector across Europe and the Middle East. With a keen focus on the nuances of Medical Device Regulation (MDR), he brings a strategic approach to recruitment. He ensures that both candidates and organisations are aligned across compliance, skills, and cultural fit.

If this sounds like a role for you or if you are seeking the right addition to your team, contact Taylor at taylor.lyons@aspirelifesciences.co.uk.