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Pmfc documentator - specialist 3, clinical research

https://www.randstad.com Logo

Randstad

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Location:
Belgium , Berchem-Sainte-Agathe

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Contract Type:
Not provided

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Salary:

Not provided

Job Responsibility:

  • Draft and maintain PMCF Plans and PMCF Evaluation Reports
  • Support in optimizing the PMCF process (SOP/templates), as part of PMS and to keep the clinical evaluation up to date
  • Review and contribute to Periodic Safety Update Reports (PSURs). Ensure alignment with PMCF findings
  • Review and contribute to Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs) and State of the Art (SoA) Protocol and Report. Ensure alignment with PMCF findings
  • Assist in data analysis and interpretation to assess product safety and performance
  • Contribute to PMCF Evaluation Reports, summarizing findings and clinical relevance
  • Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant
  • Collaborate to address feedback from Notified Bodies and Competent Authorities
  • Work closely with in Clinical Research (incl. other J&J MedTech Operating Companies) and with Scientific Operations, Regulatory Affairs, Medical Affairs, Post-Market Surveillance and other departments as appropriate
  • Support training and awareness initiatives related to PMCF to optimize collaboration

Requirements:

  • Strong writing and analytical skills
  • Attention to detail
  • Connecting the dots across different sources and cross-functional inputs
  • Preferred Experience: Medical Devices
  • Post-Market Clinical Follow-Up (PMCF)
  • Familiar with Medical Device Regulation (EU) 2017/745 and MDCG 2020-6/7/8
  • Medical writing

Additional Information:

Job Posted:
December 27, 2025

Expiration:
February 25, 2026

Employment Type:
Fulltime
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