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 Reports
* Support PMS processes and keep Clinical Evaluations up to date
* Contribute to PSURs, CERs, CEPs, SSCPs, and SoA reports, ensuring alignment with PMCF findings
* Analyze and interpret data to assess product safety and performance
* Maintain documentation for audits, inspections, and regulatory submissions
* Collaborate across Clinical Research, Regulatory Affairs, Medical Affairs, and PMS teams
* Support training and awareness initiatives to optimize PMCF collaboration
Ideal Profile:
* Strong writing and analytical skills with attention to detail
* Experience in Medical Devices and PMCF
* Familiarity with EU MDR 2017/745 and MDCG 2020‑6/7/8 guidance
* Background in medical writing and regulatory documentation