Regulatory Affairs Specialist II

Location: Irvine, CA

Hybrid - 3 days a week. Core days are Tue/Thurs (3rd onsite day a choice)

12 - Month Assignment

Pay: $45-50/hour

Are you ready to make a difference in the dynamic world of diagnostic technology? On behalf of our innovative laboratory and medical device client, we’re seeking a passionate Regulatory Affairs Specialist to support the critical transition to the EU's In Vitro Diagnostic Regulation (IVDR). This initiative impacts all products currently CE Marked under the IVD Directive. Key responsibilities include revising technical files, updating labeling to ensure IVDR compliance, tracking regional regulatory notifications, and managing related activities to ensure a smooth and successful adaptation.

Responsibilities:

• Revise and update technical files using the latest templates to ensure they clearly present product details, characteristics, and performance, demonstrating evidence of conformity with IVDR standards.
• Ensure each technical file includes the most current versions of all required documents, such as technical reports, validations, and test reports, while adhering to predefined timelines.
• Actively participate in weekly meetings to address any issues or questions related to the technical files and keep the project manager updated on progress.
• Maintain and update the labeling conversion tracking log based on the manufacturing schedule, product fill dates, product lot numbers, and change request details.
• Update the technical file tracking log and track regulatory notifications related to labeling changes.
• Coordinate with the RA SAP restriction coordinator to manage product lot distribution restrictions for specific regions.

Requirements:

• Bachelor's degree in biochemistry, biology, medical technology, or a related field.
• 3+ years of experience in Regulatory Affairs, Quality Assurance, Research & Development, Manufacturing, or Project Management in the In Vitro Diagnostics industry.
• In-depth knowledge of RA-related policies, practices, and procedures.
• Familiarity with FDA regulations and CE marking requirements for IVD products is preferred.