Regulatory Submission Specialist
Job Summary
To support the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist will manage technical documentation, ensure compliance with international IVD regulations, and coordinate evidence collection across various teams.
Key responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation
- Review product claims, instructions for use, and labelling for regulatory alignment
- Coordinate evidence collection and develop regulatory evidence plans for analytical and 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
- Experience with CE-marking documentation under the EU IVDR, including technical documentation and performance evaluation requirements
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Experience in reviewing or preparing analytical-performance and clinical-performance documentation for IVDs
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