EU IVDR Regulatory Specialist

Job Summary

To support a high-growth startup focused on women's health, the full-time remote EU IVDR Regulatory Specialist will lead the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices, ensuring compliance 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 alignment and assess supporting evidence
• Coordinate evidence collection from various internal and external teams and develop 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 in vitro diagnostic devices, including technical documentation preparation
• Experience supporting or preparing CE-marking documentation under the EU IVDR, including performance evaluation requirements
• Working knowledge of IVD quality and regulatory frameworks, including ISO standards and post-market requirements
• Experience with analytical-performance and clinical-performance documentation for IVDs, including method-comparison studies