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Katalyst CRO

Regulatory Affairs Specialist – IVDR & IVD Compliance

Katalyst CRO, Irvine, California, United States, 92713

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A leading medical technology firm is seeking a Regulatory Affairs Specialist to work on IVD products. The role involves revising technical files, ensuring compliance with FDA and CE requirements, and engaging in cross-functional projects to update labeling. Ideal candidates should hold a relevant degree and possess 3 to 5 years of experience in regulatory affairs or related fields. This position is crucial for the successful transition to IVDR regulations. #J-18808-Ljbffr