Regulatory Affairs Specialist II
📋 Role Overview & Responsibilities
Regulatory Affairs Specialist II - Irvine
Hybrid M-F 8-5 3 days on site, T,TH and tbd1 year contract $40-45/hr Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities. How You’ll Make An Impact: Support the IVDR labeling conversion and revisions of technical files for all Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.Monitor the monthly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups and product restrictions, as required.Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.
What You Bring: Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.Knowledge of FDA, and CE marking requirements for IVD products is a plusAble to work independently and with othersCommunication skills, including negotiation and persuasion.Analytical, problem solving, computer, and critical thinking skills.Thorough knowledge of policies, practices and procedures related to RA.
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This position is located in Irvine, CA with potential relocation and sponsorship assistance depending on candidate qualifications.
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