EU IVDR Regulatory Specialist
Job Summary
Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will ensure compliance by compiling technical documentation and supporting evidence throughout the product lifecycle.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and associated technical documentation
- Review product claims, labelling, and specifications for regulatory alignment
- Coordinate evidence collection from internal teams and external consultants to support regulatory submissions
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
- Experience with CE-marking documentation under the EU IVDR, including technical documentation and performance evaluation
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Experience in preparing analytical-performance and clinical-performance documentation for IVDs
Complete Job Description
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