EU IVDR Regulatory Specialist
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will manage the preparation, review, and submission of regulatory documentation, ensuring alignment with clinical, analytical, and quality evidence throughout the product lifecycle.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, labelling, and specifications for regulatory alignment
- Coordinate evidence collection and develop regulatory evidence plans for studies
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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