EU IVDR Regulatory Specialist
Job Summary
To support regulatory compliance for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will prepare and manage regulatory submission dossiers, ensuring alignment with international standards and coordinating evidence collection across teams.
Key responsibilities
- Prepare, compile, and maintain IVD regulatory submission dossiers and technical documentation
- Review product claims, instructions for use, and labelling for regulatory alignment
- Assess and confirm the adequacy of analytical, clinical-performance, and risk-management evidence
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
- Familiarity with IVD standards and guidance, particularly related to analytical and clinical-performance documentation
Complete Job Description
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