EU IVDR Regulatory Specialist

Job Summary

Supporting 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, ensuring alignment with international IVD regulatory requirements.

Key responsibilities

• Prepare and maintain IVD regulatory submission dossiers and technical documentation
• Review product claims, labelling, and specifications for regulatory alignment
• Coordinate evidence collection and develop regulatory evidence plans for clinical performance studies

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