Director Quality & Regulatory
Listed on 2026-02-12
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Management
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Healthcare
Seeking a hands‑on Director of QA/RA to own the Quality Management System and Regulatory strategy for a Class II HW/SW medical device company. This is an ideal role for a Manager/Senior Manager who is looking for their next step up to Director level.
Key ResponsibilitiesQuality Management: Full ownership of QMS maintenance and Post‑Market via QT9 (eQMS/ERP).
Design Quality: Direct Design Controls, Risk Management, and NPD for electromechanical systems.
Regulatory: Lead US 510(k) strategy; partner with external consultants and author/review technical documentation.
Supplier Quality: Manage ~50 suppliers; oversee the transition of new products to a contract manufacturing model over the next 18 months.
Team Leadership: Direct management of two reports initially
6–12 years in Med Tech QA/RA.
Direct experience with Class II Electromechanical (HW/SW) products.
Strong working knowledge of Design Controls and 510(k) submissions (submission authorship not required)
Prior experience in supplier management and QMS maintenance.
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