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Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences • Irvine, CA, US • published 2026-09-29 02:55:16.068252

Description

**Responsibilities:*** Prioritize and monitor cases throughout the day, provide status updates as necessary. * Support the IVDR labeling conversion and revisions of technical files for appropriate products that are due to convert to the new IVD Regulation. * Work cross\-functionally in weekly meetings to ensure labeling conversion follows the plan. * Monitor monthly manufacturing schedule, track change requests and monitor manufacturing timelines. * update labeling tracking log; ensuring accuracy of product lot numbers, RA regional notifications, follow\-ups and product restrictions. * Update previous revisions of IVDR Technical Files to most current template, include necessary attachments. **Requirements:*** Bachelor's degree in scientific field; biology, biochemistry, medical technology or similar. * 5\+ years of experience in Reg Affairs, QA, R\&D, Manufacturing, and/or Project Management within the IVD industry. * Knowledge of FDA, and CE marking requirements for IVD products is preferred. * Excellent verbal and written communication skills. * Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.

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