Regulatory Submission Specialist

Job Summary

Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist will compile technical documentation, ensure compliance with international IVD regulations, and coordinate evidence collection across various teams.

Key responsibilities

• Prepare, compile, and maintain IVD regulatory submission dossiers and technical documentation
• Review product claims, labelling, and specifications for regulatory alignment
• Coordinate evidence collection and identify gaps in 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 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
• Familiarity with analytical-performance and clinical-performance documentation for IVDs