EU IVDR Regulatory Specialist

Job Summary

Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will compile technical documentation, assess evidence for compliance, and coordinate with internal and external teams to ensure regulatory alignment throughout the product lifecycle.

Key responsibilities

• Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation
• Review product claims, labelling, and specifications for regulatory compliance
• Coordinate evidence collection and identify gaps in regulatory evidence plans

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
• Working knowledge of IVD quality and regulatory frameworks, including ISO standards
• Familiarity with analytical and clinical-performance documentation for IVDs