Regulatory Submission Specialist (EU IVDR)

Job Summary

To support regulatory compliance for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist (EU IVDR) will manage the preparation, review, and submission of regulatory documentation, ensuring alignment with international IVD regulatory requirements and maintaining technical documentation throughout the product lifecycle.

Key responsibilities

• Prepare, compile, 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 teams and external consultants 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 preparing CE-marking documentation under the EU IVDR
• Working knowledge of IVD quality and regulatory frameworks, including ISO standards
• Experience with analytical-performance and clinical-performance documentation for IVDs