Medical writer with 5 years of experience in creating and reviewing Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) for medical devices. Proficient in compliance with EU Medical Device Regulation (MDR) standards, ensuring high-quality documentation. Demonstrated ability in Clinical Evaluation Plan (CEP) development and Adverse Event (AE) extraction. Committed to delivering precise and regulatory-compliant medical writing solutions.
Hospital-based clinical research (June 2018 - May 2019)