PMCF (Post-Market Clinical Follow-up)

PMCF (Post-Market Clinical Follow-up)

• Location: Belgium

• Duration: 31st of December 2026

• Hours: 40 hours

Drive critical regulatory compliance and product performance assessment within the world of MedTech, ensuring life-changing medical devices remain safe and effective for patients globally.

You will be instrumental in maintaining the post-market clinical compliance of our devices, focusing on regulatory documentation, data analysis, and cross-functional strategy required under current Medical Device Regulations (MDR). This will involve:

• PMCF Documentation

  • Draft and maintain PMCF Plans and PMCF Evaluation Reports

• Post Market Surveillance (PMS) and Clinical Evaluation Support

  • 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

• Data Collection & Analysis

  • Assist in data analysis and interpretation to assess product safety and performance

  • Contribute to PMCF Evaluation Reports, summarizing findings and clinical relevance

• Regulatory Compliance

  • Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant

  • Collaborate to address feedback from Notified Bodies and Competent Authorities

• Cross-Functional Collaboration

  • 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

How to Succeed

Success in this role requires a strong regulatory mindset coupled with excellent analytical and communication skills, particularly within the complex landscape of Medical Devices. You will also bring:

• Necessary Skills:

  • Strong writing and analytical skills

  • Attention to detail

  • Connecting the dots across different sources and cross-functional inputs

• Preferred Experience:

  • Medical Devices

  • Familiar with Medical Device Regulation (EU) 2017/745 and MDCG 2020-6/7/8

  • Medical writing

Benefits

This role offers a very competitive hourly rate. This contract will run until 31st of December 2026

You Are Welcome Here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

Application Process

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.