Technical Writer

TECHNICAL WRITER & CLINICAL SPECIALIST – MEDICAL DEVICESWHAT YOU WANT TO KNOWLocation: Soesterberg, NetherlandsWorking pattern: Hybrid (3 days on-site, 2 days remote)Salary: €55,000 - €75,000 Contract: PermanentDepartment: Research & DevelopmentThis position combines technical documentation, clinical evaluation and post-market surveillance responsibilities within a regulated medical device environment.The role works closely with R&D, Regulatory Affairs, QA and product teams, ensuring technical documentation and clinical processes meet international regulatory requirements, including ISO 13485, MDR and MDD.JOB DETAILSOur client is seeking a Technical Writer & Clinical Specialist to support the development, maintenance and improvement of technical documentation related to medical device products.This position plays a key role in ensuring documentation used internally and externally, including instructions for use, technical files and development documentation is accurate, compliant and aligned with regulatory requirements.Alongside technical documentation, the role will support Clinical Evaluation and Post-Market Clinical Follow-Up (PMCF) activities, contributing to regulatory submissions, audits and risk management processes.The position sits within the R&D function and collaborates closely with Quality Assurance, Regulatory Affairs and product development teams.ROLES & RESPONSIBILITIESTechnical DocumentationWrite, edit and review technical documentation related to medical device developmentTranslate complex technical information into clear and structured documentationCreate and maintain documentation for product users, including Instructions for Use (IFU)Coordinate internal review and approval processes for technical documentationWork closely with subject matter experts to ensure accuracy and completeness of documentationClinical Evaluation & PMCFSupport Clinical Evaluation and PMCF activities in compliance with MDR and ISO standardsContribute to Post-Market Surveillance activitiesAssist with regulatory reporting including vigilance, adverse events and FSCA reportingSupport internal and external audits related to clinical evaluation and PMCF processesRisk Management & Regulatory SupportProvide clinical evaluation input to risk management processesSupport Regulatory Affairs in preparing technical documentation for regulatory submissionsUpdate risk management documentation based on clinical evaluation findingsDocumentation & Process ImprovementImprove documentation processes and storage systemsIdentify opportunities to optimise documentation workflowsContribute to continuous improvement initiatives across the organisationCross-Functional CollaborationWork with internal teams and external stakeholders on product development projectsConduct literature reviews to support clinical and regulatory activitiesProvide training and guidance on clinical evaluation and PMCF requirementsESSENTIAL EXPERIENCEMinimum 5 years’ experience in technical writing within a regulated industryExperience within the medical device sectorStrong understanding of clinical evaluation and PMCF processesFamiliarity with ISO 13485, MDR and MDD regulatory frameworksExperience producing technical documentation for multiple audiencesQUALIFICATIONSBachelor’s or Master’s degree in a technical, engineering, life sciences or related disciplineAdditional education or training in medical device regulation, clinical evaluation or quality management is advantageousTechnical writing certification or equivalent professional experience is beneficial