EU IVDR Regulatory Specialist

Job Summary

To support regulatory compliance for in vitro diagnostic devices, the full-time remote EU IVDR Regulatory Specialist will prepare and review technical documentation, manage regulatory submissions, and ensure alignment with international regulatory requirements.

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 internal teams and external consultants while identifying evidence gaps and developing 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 preparation of technical documentation
• Experience supporting CE-marking documentation under the EU IVDR, including technical documentation and performance evaluation requirements
• Working knowledge of IVD quality and regulatory frameworks, including ISO 13485 and ISO 14971
• Experience reviewing or preparing analytical-performance and clinical-performance documentation for IVDs