Regulatory Affairs Specialist (IVD)

This is an exciting opportunity to join an industry leading biotech company leading. The Regulatory Affairs Specialist will be responsible for supporting In Vitro Diagnostic Regulation (IVDR) transition activities that impact products currently CE Marked under the IVD Directive. This includes preparing revision of technical files as needed, updating labeling to comply with IVDR requirements, tracking regional notifications, etc.Responsibilities:Prioritize and monitor cases throughout the day, provide status updates as necessarySupport 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 planMonitor monthly manufacturing schedule, track change requests and monitor manufacturing timelinesUpdate labeling tracking log; ensuring accuracy of product lot numbers, RA regional notifications, follow-ups and product restrictionsUpdate previous revisions of IVDR Technical Files to most current template, include necessary attachments. Requirements and Desired Experience:Bachelor's degree in scientific field; biology, biochemistry, medical technology or similar3+ years of experience in Reg Affairs, QA, R&D, Manufacturing and/or Project Management within the IVD industryKnowledge of FDA, and CE marking requirements for IVD products is preferredExcellent verbal and written communication skillsThorough knowledge of policies, practices and procedures related to Regulatory AffairsCompensation: $40-50 per hourContract Duration: 1 year

Created: 2024-11-10