EU IVDR Regulatory Specialist
Job Summary
To support the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will manage the compilation of technical documentation, ensure regulatory compliance, and coordinate evidence collection across various teams.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and associated technical documentation
- Review product claims, instructions for use, and labelling for regulatory alignment
- Support the preparation of clinical-performance documentation and respond to regulatory authority inquiries
Required qualifications
- Bachelor's degree in Regulatory Affairs, Biomedical Science, Medical Laboratory Science, Biotechnology, Engineering, Life Sciences, or a related discipline
- 2+ years of experience in regulatory affairs for medical devices or in vitro diagnostic devices
- Experience with CE-marking documentation under the EU IVDR, including technical documentation and performance evaluation requirements
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Experience preparing analytical-performance and clinical-performance documentation for IVDs
Complete Job Description
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