Job Description
Director of Quality & Regulatory Affairs – Class III Medical Devices
Location: Near Stoke on Trent (Hybrid – Onsite 3 days/week)
Sector: Medical Devices - Class III | Global Markets
A leader in the development and manufacturing of cutting-edge, medical device business is seeking an experienced Director of Quality & Regulatory Affairs to join their senior leadership team. This is a pivotal role in a company committed to saving lives through innovation and rigor in medical device development.
Key Responsibilities:
1. Lead and evolve the global Quality & Regulatory strategy across a high-performing portfolio of Class IIb and III medical devices.
2. Spearhead the preparation, authorship, and submission of FDA 510(k) applications, ensuring compliance with U.S. regulatory pathways.
3. Direct the successful transition from MDD to MDR, with robust oversight of ongoing EU regulatory compliance.
4. Oversee the implementation and continual improvement of a harmonized Quality Management System aligned with ISO 13485 and FDA regulations.
5. Collaborate with Clinical Affairs to support clinical evaluations, PMCF activities, and study oversight.
6. Engage with cross-functional stakeholders including R&D, manufacturing, and commercial ...