Regulatory Submission Specialist
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist will prepare and review regulatory documentation, ensuring alignment with EU IVDR requirements while collaborating with cross-functional teams.
Key responsibilities
- Prepare and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, labelling, and specifications for regulatory alignment
- Assess evidence related to analytical and clinical performance to confirm device claims
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 or in vitro diagnostic devices
- Experience with CE-marking documentation under the EU IVDR
- Working knowledge of IVD quality and regulatory frameworks, including ISO standards
- Experience in preparing analytical-performance and clinical-performance documentation for IVDs
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