Regulatory Affairs Specialist – IVDD to IVDR Transition

Regulatory Affairs Specialist – IVDD to IVDR Transition Location: Apeldoorn, The Netherlands (on-site/remote) Position: Part-time (24–32 hours/week), Fixed-term Industry: Medical Devices About Biozek Biozek is an innovative medical device manufacturer specializing in rapid diagnostic tests and Point of Care (POC) systems. With a global footprint, we supply our high-quality products to over 50 countries, serving hospitals, laboratories, wholesalers, and governmental institutions. Our product portfolio currently falls under the In Vitro Diagnostic Directive (IVDD), and we are actively transitioning to meet the new In Vitro Diagnostic Regulation (IVDR) requirements. About the Role We are seeking a proactive and detail-oriented Regulatory Affairs Specialist to support our transition from IVDD to IVDR compliance. In this role, you will be responsible for preparing and converting documentation, liaising with suppliers, and ensuring adherence to our ISO 13485 quality management system. Key Responsibilities · Prepare and update regulatory documentation to support the transition from IVDD to IVDR. · Request and collect required certificates and documentation from component and material suppliers. · Review and verify technical data for accuracy and completeness in accordance with internal procedures. · Ensure compliance with our ISO 13485 quality management system. · Assist in the creation, organization, and maintenance of regulatory records and registration files. · Maintain regulatory data and confidential documents according to internal policies. · Coordinate small-scale projects and timelines in collaboration with internal departments. Qualifications · Bachelor’s degree (applied sciences or equivalent) in a relevant field (e.g. science, quality, legal), or at least one year of practical experience in one of these areas. · Previous experience or familiarity with regulatory affairs, medical devices, pharmaceuticals, quality control or assurance is preferred. · Strong organizational skills and high attention to detail. · Ability to work independently within defined procedures. · Fluent in English (spoken and written); Dutch is not required. · Proficiency with Microsoft Office tools (Excel, Word, Outlook). · Applicants residing outside of The Netherlands are welcome to apply. What We Offer · A flexible, part-time position (24–32 hours/week), perfect for candidates starting their career, returning to the workforce, or looking for work-life balance. · A good salary aligned with your experience and qualifications. · The opportunity to contribute directly to a crucial regulatory transition in a fast-growing, international company. Ready to join us? Send us your CV and a short cover letter outlining your motivation and relevant experience to Mr. Mustafa Hamid (General Manager) mustafa@biozek.com.

Location: Apeldoorn, Gelderland, NL

Posted Date: 7/20/2025