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 international requirements and maintaining technical documentation throughout the product lifecycle.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, labelling, and specifications for regulatory compliance
- Coordinate evidence collection and develop regulatory evidence plans for studies
Required qualifications
- Bachelor's degree in Regulatory Affairs, Biomedical Science, or related field
- 2+ years of experience in regulatory affairs for medical or in vitro diagnostic devices
- Experience with CE-marking documentation under the EU IVDR
- Knowledge of IVD quality and regulatory frameworks, including ISO standards
- Experience in preparing analytical and clinical-performance documentation for IVDs
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