Specialist regulatory affairs
il y a 2 semaines
PMCF Specialist (Medical Devices / Clinical & Regulatory Affairs)
Start Date: ASAP
Contract Duration: 12 months (possibility of extension)
As a PMCF Specialist, you will join the Clinical and Regulatory Affairs team at a leading global healthcare company’s Medical Devices division in Diegem, Belgium.
You will collaborate with cross-functional experts across Clinical Research, Regulatory Affairs, and Post-Market Surveillance, driving compliance with the EU Medical Device Regulation (MDR 2017/745) and contributing to the continuous improvement of clinical evaluation processes and documentation.
Data Collection & Analysis
~ Contribute to PMCF Evaluation Reports, summarizing clinical findings, data trends, and their regulatory relevance.
Collaborate with internal partners across Clinical Research, Scientific Operations, Regulatory Affairs, Medical Affairs, and Post-Market Surveillance.
Contribute to internal training and awareness initiatives to strengthen PMCF understanding and implementation across teams.
Experience in Medical Device industry.
Familiarity with Medical Device Regulation (EU) 2017/745 and related MDCG 2020-6/7/8 guidance documents.
Background in medical writing or regulatory documentation.
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