Regulatory Submission Specialist (EU IVDR)
Job Summary
Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist (EU IVDR) will manage technical documentation, ensure compliance with international regulations, and collaborate with cross-functional teams 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 and assess documentation to confirm compliance with intended device purposes
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 (Regulation (EU) 2017/746)
- Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
- Familiarity with relevant IVD standards and guidance, including CLSI EP guidelines
Complete Job Description
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