Regulatory Submission Specialist (EU IVDR)
Job Summary
To support the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist (EU IVDR) will manage the compilation of technical documentation, review product claims for regulatory alignment, and coordinate evidence collection across various teams.
Key responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation
- Review intended-use statements, product claims, and labelling for regulatory compliance
- Coordinate evidence collection from internal and external stakeholders 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 IVDs, including technical documentation preparation
- 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 analytical-performance and clinical-performance documentation for IVDs
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