R&D Manager
- Location
- Greater London, England, United Kingdom
reporting to leadership Own the Design History File (DHF) — content and timeline — aligned to the regulatory submission schedule Lead design transfer into manufacture: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issues with a contract manufacturer Act as the central coordination point across engineering, clinical affairs … devices through development, design transfer, and regulatory submission, including at least one product transferred into validated production Direct, evidenced experience of design transfer: process validation, manufacturing documentation, and resolution of design-for-manufacture and yield issues Strong understanding of ISO 13485, design controls, and FDA 510(k) or CE-mark ...