Medical Writer

In this hands‐on role, you'll be at the heart of Post‐Market Clinical Follow‐Up (PMCF) and Post‐Market Surveillance (PMS) activities—driving best practices, ensuring compliance, and shaping smarter, safer medical technologies. You'll draft and maintain PMCF plans and evaluation reports, align findings across clinical evaluations, and contribute to critical regulatory documentation such as PSURs, CERs, CEPs, SSCPs, and State of the Art reports.With a strong emphasis on data analysis, regulatory compliance, and cross‐functional collaboration, you'll work closely with Clinical Research, Regulatory Affairs, Medical Affairs, and Scientific Operations to ensure product safety and performance remain at the highest standards. Ideal candidates will bring sharp analytical skills, medical writing expertise, and familiarity with EU MDR requirements.This is more than a documentation role—it's a chance to be a catalyst for clinical excellence and patient safety in a cutting‐edge medical device environment.Key Responsibilities:Draft and maintain PMCF Plans and Evaluation ReportsSupport PMS processes and keep Clinical Evaluations up to dateContribute to PSURs, CERs, CEPs, SSCPs, and SoA reports, ensuring alignment with PMCF findingsAnalyze and interpret data to assess product safety and performanceMaintain documentation for audits, inspections, and regulatory submissionsCollaborate across Clinical Research, Regulatory Affairs, Medical Affairs, and PMS teamsSupport training and awareness initiatives to optimize PMCF collaborationIdeal Profile:Strong writing and analytical skills with attention to detailExperience in Medical Devices and PMCFFamiliarity with EU MDR 2017/745 and MDCG 2020‐6/7/8 guidanceBackground in medical writing and regulatory documentation