jobid=A.0.0397
Unity Partners on behalf of our HealthTech partnerWe are currently seeking a QARA Specialist for a fast-growing and purpose-driven HealthTech scale-up. In this role, you’ll take ownership of the company’s compliance operations and quality frameworks, working hands-on while collaborating closely with management, product, tech, and medical experts. You’ll have a direct impact on regulatory success, business continuity, and patient safety.This is a unique opportunity for a proactive compliance professional to become the central figure in maintaining and advancing the company’s quality and information security frameworks. You’ll oversee both ISO 27001 / NEN 7510 and support the roadmap towards ISO 13485 and CE marking in collaboration with external MDR specialists. You’ll get the chance to build your own team and enjoy operational execution at the same time.Key ResponsibilitiesMaintain and improve compliance with ISO 27001 and NEN 7510 standards, including audits, risk assessments, and CAPAsDevelop and implement the QMS in preparation for ISO 13485 certificationLead CE-marking activities in collaboration with external MDR specialistsManage and update technical documentation, including post-market surveillance obligationsAct as primary liaison for regulatory bodies and manage compliance incident reportingConduct internal audits and risk assessments across departmentsDrive awareness and training around compliance and quality culture within the organizationEnsure up-to-date registrations and communications with relevant authoritiesYour Profile5+ years of experience in a QA, RA, or compliance role within healthcare or HealthTechProven experience with ISO 27001 and/or NEN 7510 frameworksFamiliarity with ISO 13485 and MDR (CE-marking processes) is a strong advantageHands-on, structured, and proactive mindset with strong ownership mentalityFluent in Dutch or English (both spoken and written)Strong communicator who enjoys collaborating with multidisciplinary teamsComfortable working in a solo role within a dynamic, fast-moving environmentOrganization & OfferYou’ll join a mission-driven digital health innovator shaping the future of patient care. The company is scaling rapidly and offers a flat, informal culture where initiative and responsibility are encouraged. You can expect a competitive salary, personal development budget, and the opportunity to build a best-in-class compliance function from the ground up.INTERESTED?For more information or to apply directly, please contact Christian Steenkamp at +31 (0) 20 8938 606 or via email at christian@unitypartners.nl
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