Job Description
Job Summary:
A pioneering medical technology company focused on advanced wound care and regenerative therapies is seeking a Director of Quality Assurance & Regulatory Affairs to lead its global quality and compliance function.
Key Responsibilities:
1. Lead internal and external audits, including CAPA systems, non-conformance investigations, and supplier qualification efforts.
2. Develop and maintain company-wide quality metrics and executive-level reporting that drive continuous improvement and regulatory alignment.
3. Provide regulatory leadership and input into clinical and preclinical programs, ensuring protocols meet global submission standards.
4. Manage all regulatory submissions, including FDA 510(k), PMA, CE Mark Technical Files, and global market applications.
5. Build and evolve a globally aligned Quality Management System (QMS) compliant with ISO 13485, FDA 21 CFR Part 820, and MDSAP standards.
6. Take ownership of design control, risk management (ISO 14971), and quality governance across R&D, manufacturing, and post-market surveillance.
7. Act as the principal liaison for regulatory authorities and notified bodies, including oversight of inspections and compliance reviews.
8. Monitor global regulatory developments (EU MDR, FDA, EMA) and ensure proactive strategy updates to maintain global com...