EU IVDR Regulatory Specialist
Job Summary
Seeking a full-time remote EU IVDR Regulatory Specialist, the successful candidate will lead the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices, ensuring compliance 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 clinical performance studies
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, including technical documentation preparation
- Experience with CE-marking documentation under the EU IVDR, including performance evaluation requirements
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Experience reviewing analytical-performance and clinical-performance documentation for IVDs
Complete Job Description
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