PMCF Specialist

PMCF Specialist (Medical Devices / Clinical & Regulatory Affairs)

• Start Date: ASAP
• Contract Duration: 12 months (possibility of extension)
• Location: Diegem, Belgium

Job Description

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.

In this role, you will play a key part in ensuring ongoing product safety and performance through robust Post-Market Clinical Follow-Up (PMCF) activities. 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.

Key Responsibilities

PMCF Documentation

• Draft, update, and maintain PMCF Plans and PMCF Evaluation Reports in line with MDR and internal procedures.

Post-Market Surveillance (PMS) and Clinical Evaluation Support

• Support optimization of the PMCF process, including SOPs and templates, ensuring alignment with PMS activities and clinical evaluations.
• Review and contribute to Periodic Safety Update Reports (PSURs), Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs), and State of the Art (SoA) protocols and reports.
• Ensure consistency and alignment across PMCF findings and associated documentation.

Data Collection & Analysis

• Contribute to PMCF Evaluation Reports, summarizing clinical findings, data trends, and their regulatory relevance.

Regulatory Compliance

• Maintain and organize documentation for audits, inspections, and regulatory submissions.
• Support audit preparation and participate in interactions with Notified Bodies and Competent Authorities, ensuring timely and compliant responses.

Cross-Functional Collaboration

• 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.

Essential Skills

• Experience in Medical Device industry.
• Knowledge of Post-Market Clinical Follow-Up (PMCF) processes.
• Familiarity with Medical Device Regulation (EU) 2017/745 and related MDCG 2020-6/7/8 guidance documents.
• Background in medical writing or regulatory documentation.

Interested? Apply here or send your CV to m.spinetta@panda-int.com