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, review, and submission of regulatory documentation while ensuring alignment with international IVD regulatory requirements.

Key responsibilities

• Prepare and maintain IVD regulatory submission dossiers and associated technical documentation
• Review product claims, labelling, and specifications for regulatory alignment
• Coordinate evidence collection and develop regulatory evidence plans to address evidence gaps

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 with analytical-performance and clinical-performance documentation for IVDs