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 technical documentation, ensure regulatory compliance, and coordinate evidence collection across teams.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, labelling, and specifications for regulatory alignment
- Support post-market regulatory activities, including vigilance reporting and documentation updates
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
- Familiarity with analytical and clinical-performance documentation for IVDs
Complete Job Description
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