EU IVDR Regulatory Specialist

Job Summary

Seeking a full-time remote EU IVDR Regulatory Specialist, the candidate will manage the preparation, review, and submission of regulatory documentation for in vitro diagnostic devices, ensuring compliance 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 various 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 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, such as ISO 13485 and ISO 14971
• Familiarity with relevant IVD standards and guidance, with experience in self-tests or consumer-use IVDs highly desirable