This is a 9-month contract opportunity to join a global medical devices organization to drive the strategy and overall completion of the CERs under MEDDEV 2.7/1. Fully remote and part of the experienced medical writing team.
Main Responsibilities
- Perform systematic literature searches and reviews for clinical regulatory document creation.
- Write, edit, and proofread Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) plans and evaluation reports, Summary of Safety and Clinical Performance (SSCP), Post-market Surveillance (PMS) plans, Post-market Surveillance reports (PMSRs), and Periodic Safety Update reports (PSURs)
Experience Required:
- 2 years' experience writing Clinical Evaluation Reports (CERs) for Medical Device products in accordance with EU MDR.
- Available from January 2025.