Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Irvine, CA 92602
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences
