Significant project and programme management experience with medical devices and in-vitro diagnostics. Developed and launched complex products via CE marking and FDA (PMA, Real-time) submission processes.• Product Development• Project Management• Design Control• Risk Management• Regulatory Submission (CE, FDA, Japanese PMDA)• Medical Devices• In-vitro Diagnostic Devices• ISO 13485 – Medical Device: Quality Management System• ISO 14971 – Medical device: Application of Risk Management• ISO 25539 – Cardiovascular implants: Endovascular Devices• ISO 10993 – Biological Evaluation of Medical Devices• EN 60601-1 – Medical Electrical Equipment• Design Verification and Validation• Software Validation