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.