Documentatiespecialist

Ignite Innovation in Advanced Therapies: Post-Market Clinical Follow-Up (PMCF) Specialist

Are you ready to shape the future of patient care?

Our client is a global leader and pioneer in the cutting-edge field of advanced therapies , with a deep commitment to the development and delivery of groundbreaking cell therapies , particularly within the high-impact CAR-T domain . We are seeking a detail-oriented and analytical professional to join the team as a PMCF Specialist to ensure the continued safety and performance of their life-changing products in line with stringent international regulations.

🎯 As the PMCF Specialist, you will play a crucial role in ensuring post-market compliance and the continuous clinical evaluation of our client’s advanced therapy products. PMS and Clinical Evaluation Support:
Actively support the optimization of the PMCF process (SOP/templates), integrating it seamlessly into the broader Post Market Surveillance (PMS) system to keep the Clinical Evaluation up-to-date.
Critically review and contribute to key clinical documentation including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summaries of Safety and Clinical Performance (SSCPs) , and the State of the Art (SoA) Protocol and Report , always ensuring alignment with PMCF data.
Data Collection & Analysis:
Assist in the robust analysis and interpretation of collected data to accurately assess product safety and performance.
Cross-Functional Collaboration & Training:
Work closely with internal Clinical Research teams (including other J&J MedTech Operating Companies), Scientific Operations, Regulatory Affairs, Medical Affairs, and Post-Market Surveillance to achieve project goals.
Support essential training and awareness initiatives related to PMCF to foster optimal cross-departmental collaboration.

✅ Exceptional Writing & Analytical Skills: The ability to translate complex data and regulatory requirements into clear, precise, and professional documentation.
Proven ability to connect insights across different data sources and synthesize input from various cross-functional stakeholders.

Proven experience in the Medical Devices or Advanced Therapies sector.
Familiarity with the Medical Device Regulation (EU) 2017/745 and relevant guidance documents such as MDCG 2020-6/7/8 is highly valued.
Experience with Medical Writing for regulatory or clinical purposes.

🎁 This role is a unique opportunity to advance your career in a sector that is fundamentally changing medicine. You will be employed via a Randstad Professional contract , which offers the stability and growth opportunities of a trusted global partner.
Your attractive salary package and benefits as a Randstad Professional Consultant include:
Net Allowance: An additional net allowance of €80 per month , on top of your net salary.
Financial Perks: Meal Vouchers and Ecocheques (€250 per year) .
Commitment to Growth: Access to numerous training courses , career development opportunities, and engaging activities to guide your professional journey.
Are you the PMCF expert ready to drive compliance and clinical evaluation for life-saving therapies?