Regulatory Affairs Specialist III – IVD (Temporary)

Bio-Rad Laboratories, Inc; Irvine (CA); Hybrid; USD 110,000 - 140,000; Part time

Job summary

Bio-Rad Laboratories, Inc. in Irvine, CA is seeking a Regulatory Affairs Specialist III - Temporary to support new product developments, IVDR implementation, and international registrations. The role is projected to end March 1, 2027.

Responsibilities include managing global regulatory submissions, labeling compliance, and coordinating with cross-functional teams. The candidate should have a Bachelor's degree in a relevant science, 5+ years in regulatory affairs, and knowledge of FDA/IVDR.

Qualifications

• Bachelor's degree in Biology, Chemistry, Medical Technology, or 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 in IVD.
• Extensive knowledge of FDA, NPMA and IVDR regulatory requirements.

Responsibilities

• Manage global regulatory submissions, registrations, renewals, and maintenance activities across international markets.
• Ensure product labeling, IFUs, and supporting documentation meet global regulatory requirements.
• Coordinate responses to regulatory authority questions with cross-functional partners.
• Maintain audit-ready records and manage regulatory changes in SAP.
• Support CE marking and international registrations.
• Coordinate labeling changes and communicate updates to regions and stakeholders.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory writing

Attention to detail

SAP

Statistical analysis

Education

Bachelor's degree in Biology/ Chemistry/ Medical Technology

Regulatory Affairs Certification (RAC) preferred

Tools

SAP

Job description

Bio-Rad Laboratories, Inc. in Irvine, CA is seeking a Regulatory Affairs Specialist III - Temporary to support new product developments, IVDR implementation, and international registrations. The role is projected to end March 1, 2027.

Responsibilities include managing global regulatory submissions, labeling compliance, and coordinating with cross-functional teams. The candidate should have a Bachelor's degree in a relevant science, 5+ years in regulatory affairs, and knowledge of FDA/IVDR.