PMCF Documentation Specialist

Science
1831 DIEGEM
Project Sourcing of Freelance
Nederlands
Master
40 u/week
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Functieomschrijving

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.

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

Profiel

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

Aanbod

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.

Bedrijfsinfo

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.

Heb je interesse in deze vacature?

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