EU IVDR Regulatory Specialist

Job Summary

To support regulatory compliance for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will manage the preparation and submission of regulatory documentation, ensuring alignment with international IVD requirements and maintaining technical documentation 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 from various internal and external stakeholders 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 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 standards
• Experience preparing analytical-performance and clinical-performance documentation for IVDs