EU IVDR Regulatory Specialist
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will lead the preparation and submission of regulatory documentation, ensuring alignment with international IVD requirements and maintaining technical documentation throughout the product lifecycle.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and associated technical documentation
- Review product claims, labelling, and specifications for regulatory alignment
- Coordinate evidence collection and assess documentation for compliance with regulatory standards
Required qualifications
- Bachelor's degree in Regulatory Affairs, Biomedical Science, or a related discipline
- 2+ years of experience in regulatory affairs for medical or in vitro diagnostic devices
- Experience with CE-marking documentation under the EU IVDR
- Working knowledge of IVD quality and regulatory frameworks, including ISO standards
- Experience with analytical and clinical-performance documentation for IVDs
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