RA Specialist III - Temporary Non-Employee

Bio-Rad Laboratories, Inc; Irvine (CA); On-site; USD 68,000 - 97,000; Full time

Job summary

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

You will manage global submissions, ensure labeling and documentation compliance, coordinate regulatory responses with cross-functional teams, maintain audit-ready records, and support CE Marking activities. A life sciences degree, 5+ years in regulatory affairs, and RAC preferred; SAP experience

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 the in vitro diagnostics (IVD) industry.
• Extensive knowledge of global regulatory requirements, including FDA, NMPA 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 regulatory writing skills.
• Proficient in computer applications, including Quality Management 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

Responsibilities

• 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.

Skills

Regulatory affairs

Global regulatory knowledge

Regulatory writing

Statistical analysis

Cross-functional collaboration

Education

Bachelor’s degree in life sciences

Advanced degree or RAC preferred

Tools

SAP

Job description

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.