Leading the preparation and submission of regulatory documentation for in vitro diagnostic devices, the full-time remote Regulatory Submission Specialist will ensure compliance with EU IVDR requirements while compiling technical documentation and coordinating evidence collection across teams. Key responsibilities Prepare 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 teams and develop 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 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 with analytical and clinical-performance documentation for IVDs
Regulatory Submission Specialist in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.