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 coordinate evidence collection from various teams.

Key responsibilities

• Prepare, compile, and maintain IVD regulatory submission dossiers and associated technical documentation
• Review product claims, intended-use statements, and labelling for regulatory alignment
• Assess and coordinate evidence collection for analytical, clinical-performance, and usability studies

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, including technical documentation preparation
• Experience with CE-marking documentation under the EU IVDR, including performance evaluation requirements
• Working knowledge of IVD quality and regulatory frameworks, including ISO standards
• Experience with analytical-performance and clinical-performance documentation for IVDs