Location: Diegem, Belgium
Workload: Full-time
Working Model: Hybrid (3 days onsite / 2 days remote)
Project Duration: Until 31/12/2026 (extension possible)
Contract Type: Consultancy via USG Professionals (permanent contract or freelance)
Start Date: ASAP
Are you passionate about high-impact clinical documentation that helps ensure medical devices remain safe and effective for patients worldwide?
Do you enjoy scientific writing and working in a highly regulated environment where accuracy truly matters?
We are looking for a PMCF Documentation Specialist to join a global leader in the Medical Devices industry.
This is a rare long-term opportunity in a small, growing PMCF team that plays a critical role in MDR compliance and patient safety.
You will be hired as a consultant via USG Professionals (on a permanent contract or as a freelancer) and work on-site with the client’s Clinical Research organization.
About the Role
As PMCF Documentation Specialist, you will work in a compact, specialized PMCF team within Clinical Research.
The team is currently expanding and aims to build long-term stability and expertise.
Although the function is connected to clinical studies, it is not part of post-market study operations and has no project management responsibilities.
Study teams provide the clinical and performance data, your core mission is to translate that information into high-quality, compliant PMCF documentation aligned with MDR.
This is a hands-on writing, reviewing and analytical role, ideal for someone who enjoys deep work, scientific rigor and document quality.
Key Responsibilities
* Write, review and maintain PMCF Plans and PMCF Evaluation Reports (PMCF ERs)
* Review technical and clinical documents including CERs, CEPs, SSCPs, PSURs and State of the Art papers
* Interpret data provided by study teams and integrate findings into PMCF deliverables
* Ensure consistency and alignment across PMCF, PMS and Clinical Evaluation documentation
* Support audits by providing documentation-related clarification
* Uphold MDR compliance, scientific accuracy and high-quality writing standards
* Collaborate with Clinical Research, PMS, Medical Affairs and Regulatory Affairs
Candidate Profile
Must-Have
* Recent experience with PMCF documentation and MDR requirements
* Strong experience in writing or reviewing clinical, medical or technical documentation
* Excellent command of Dutch and English (written & spoken)
* Strong analytical mindset with high attention to detail
* Comfortable in a documentation-driven, regulated environment
* Degree in Biomedical Sciences, Life Sciences, Pharmaceutical Sciences or similar
Nice-to-Have
* Experience within the Medical Devices or Clinical Research domain
Soft Skills
* Meticulous, structured and analytical
* Thrives in a niche, specialized discipline
* Enjoys scientific writing and deep-focus documentation work
* Long-term mindset, the team seeks someone who wants to stay for several years
* Strong communicator and team collaborator
Offer
As a Project Consultant:
* A permanent contract with a competitive salary package, including: a monthly expense allowance, company car and fuel card (or a monthly gross bonus), €8 meal vouchers, group and hospitalization insurance, a mobile phone subscription, and a year-end bonus. This attractive package is complemented by Benefits at Work access, sports & culture vouchers, and eco vouchers.
* A varied and dynamic training program, including both job-specific and general professional courses.
* Regular feedback and check-ins with your assigned HR Business Partner.
* The opportunity to connect with fellow consultants at networking events and team-building activities.
* Kickstart your career with USG Professionals’ exclusive 2-day Bootcamp!
As a Freelancer:
Streamline your career with the USG EASY app:
* Receive personalized project offers based on your profile and availability.
* Transparent tracking of your invoicing process.
* Manage all your administration in one app.
Engage in regular networking events with leading companies and fellow freelancers during our Innovation Meetups.