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 compliance with international regulations, and coordinate evidence collection across various 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 change assessments and adverse-event reporting
Required qualifications
- Bachelor's degree in Regulatory Affairs, Biomedical Science, or related discipline
- 2+ years of experience in regulatory affairs for medical devices or IVDs
- Experience with CE-marking documentation under the EU IVDR
- 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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