EU IVDR Regulatory Specialist

Job Summary

To support the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will manage the compilation of technical documentation, ensure regulatory compliance, and collaborate with cross-functional teams throughout the product lifecycle.

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 assess documentation to confirm compliance with intended purposes and 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 devices or IVDs, including preparation of technical documentation
• Experience with CE-marking documentation under the EU IVDR, including performance evaluation requirements
• Working knowledge of IVD quality and regulatory frameworks such as ISO 13485 and ISO 14971
• Familiarity with relevant IVD standards and guidance, including CLSI EP guidelines