Senior Clinical Evaluation Medical Writer- Cardiac Surgery
Current• Prepare regulatory documents for cardiac surgery devices.• Interpret primary literature for appropriateness and statistical significance. • Collaborate with others to build Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-market Clinical Follow-up Plans and Reports (PMCF), and Periodic Safety Update Reports (PSUR) for device approval/maintenance of approval within EU Medical Device Regulation (MDR).