EU IVDR Regulatory Specialist

Job Summary

Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will compile technical documentation, review product claims, and ensure compliance throughout the product lifecycle.

Key responsibilities

• Prepare and maintain IVD regulatory submission dossiers and associated technical documentation
• Review product claims, intended-use statements, and labelling for regulatory alignment
• Coordinate evidence collection from internal and external teams 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 13485 and ISO 14971
• Familiarity with relevant IVD standards and experience with analytical and clinical-performance documentation