PMCF Documentation Specialist

Location: Diegem, BelgiumWorkload: Full-timeWorking 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: ASAPAre 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 RoleAs 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 ResponsibilitiesWrite, 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 papersInterpret data provided by study teams and integrate findings into PMCF deliverablesEnsure consistency and alignment across PMCF, PMS and Clinical Evaluation documentationSupport audits by providing documentation-related clarificationUphold MDR compliance, scientific accuracy and high-quality writing standardsCollaborate with Clinical Research, PMS, Medical Affairs and Regulatory AffairsCandidate ProfileMust-HaveRecent experience with PMCF documentation and MDR requirementsStrong experience in writing or reviewing clinical, medical or technical documentationExcellent command of Dutch and English (written & spoken)Strong analytical mindset with high attention to detailComfortable in a documentation-driven, regulated environmentDegree in Biomedical Sciences, Life Sciences, Pharmaceutical Sciences or similarNice-to-HaveExperience within the Medical Devices or Clinical Research domainSoft SkillsMeticulous, structured and analyticalThrives in a niche, specialized disciplineEnjoys scientific writing and deep-focus documentation workLong-term mindset, the team seeks someone who wants to stay for several yearsStrong communicator and team collaboratorOfferAs 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.