Regulatory Affairs Specialist

Regulatory Affairs Specialist (IVDR)***** Irvine, CA. (HYBRID T/TH 3rd day of choice )12 Month Assignment (Potential to Extend)Pay rate $45–$50/hr. DOEOn behalf of our client a medical device company we are seeking for a Regulatory Affairs Specialist to support in their transition efforts for the EU’s In Vitro Diagnostic Regulation (IVDR). This role will play a critical part in ensuring all CE-marked IVD products comply with the latest regulatory requirements. The position involves technical file preparation, labeling updates, regulatory notifications, and cross-functional project coordination.Main **Ensure technical files clearly describe product characteristics, performance claims, and evidence of conformity.Compile required documentation (e.g., validation reports, test data) into each technical file per the defined table of contents.Support the IVDR labeling conversion project in collaboration with cross-functional teams.Update the labeling conversion tracking log using manufacturing schedules, fill dates, lot numbers, and change request information.Modify labeling specifications as needed to meet IVDR standards.Product De-Certification SupportAssist with the process of un-CE marking selected products.Ensure all associated labels reflect the removal of the CE mark according to defined specifications.Maintain technical file and labeling tracking logs.Coordinate regional regulatory notifications and document changes appropriately.**Bachelor’s degree in Biochemistry, Biology, Medical Technology, or related field.3+years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry.Working knowledge of FDA and CE marking requirements is highly desirable.Proficient in Microsoft Office and regulatory documentation systems.Please submit a copy of your resume in Word or PDF format to be considered.

Created: 2025-07-09