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 and ensure compliance with international IVD regulatory requirements.

Key responsibilities

• Prepare, compile, and maintain IVD regulatory submission dossiers and technical documentation
• Review product claims, instructions for use, and labelling for regulatory alignment
• Coordinate evidence collection from internal teams and external consultants to support regulatory submissions

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, including performance evaluation requirements
• Working knowledge of IVD quality and regulatory frameworks, including ISO standards
• Experience in reviewing analytical and clinical-performance documentation for IVDs