RA Specialist III - Temporary Non-Employee
- 2026-39288
- Irvine, California, United States
- Quality & Regulatory
- Hybrid
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Bio-Rad is looking for a Regulatory Affairs Specialist III to join our Irvine, CA office. In this position you will support new product developments/product modifications, IVDR implementation, and international product registrations. This is a temporary role projected to end March 1, 2027.
Perform other Regulatory Affairs responsibilities and special projects as assigned.
How you will make an impact:
- Manage global regulatory submissions, registrations, renewals, and maintenance activities to support new and modified products across international markets.
- Ensure product claims, labeling, IFUs, and supporting documentation meet applicable global regulatory requirements.
- Coordinate responses to regulatory authority questions and information requests with cross-functional partners.
- Manage Regulatory Affairs change requests and maintain audit-ready records.
- Maintain technical documentation to support CE Marking and applicable regulatory requirements.
- Coordinate labeling changes and communicate updates to regions and stakeholders.
- Manage SAP product restrictions to ensure regulatory compliance.
- Perform other Regulatory Affairs responsibilities and special projects as assigned.
What you bring:
- Bachelor''s degree in Biology, Chemistry, Medical Technology, or a related scientific discipline.
- Advanced degree and/or Regulatory Affairs Certification (RAC) preferred.
- 5 + years of experience in domestic and international regulatory affairs or regulatory compliance, preferably within the in vitro diagnostics (IVD) industry.
- Extensive knowledge of global regulatory requirements, including FDA, NPMA and IVDR.
- Extensive knowledge of product labeling requirements and international product registration processes.
- Strong customer focus with the ability to support cross-functional and external stakeholders.
- Detail-oriented with strong technical and regulatory writing skills.
- Proficient in computer applications, including Quality Manament systems such as SAP.
- The ability to perform basic statistical analysis.
- Strong analytical, communication, problem solving, and critical thinking skills.
- Demonstrated ability to multitask and manage competing priorities across multiple timelines
Pay Rate $60.00 per hour
Schedule 8 am - 5 pm Monday to Friday
Assignment Duration - 6 months
Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.