RA Specialist III - Temporary Non-Employee

Bio-Rad Laboratories; Irvine (CA); On-site; USD 120,000 - 130,000; Full time

Job summary

Bio-Rad Laboratories in Irvine, CA, is seeking a Regulatory Affairs Specialist III to support new product developments, IVDR implementation, and international product registrations in a temporary role.

You will manage global submissions, ensure labeling and documentation compliance, coordinate with cross-functional partners, and maintain audit-ready records while supporting CE marking requirements.

Qualifications

• Bachelor's degree in Biology, Chemistry, Medical Technology, or a related scientific discipline.
• Advanced degree and/or RAC preferred.
• 5+ years of experience in domestic and international regulatory affairs, preferably within the in vitro diagnostics (IVD) industry.
• Extensive knowledge of FDA, NPMA and IVDR.
• Extensive knowledge of labeling requirements and international product registrations.
• Strong customer focus with the ability to support cross-functional and external stakeholders.
• Detail-oriented with strong technical and regulatory writing skills.
• Proficient in SAP and other quality systems.
• 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 submissions

Regulatory writing

Project management

Cross-functional collaboration

Analytical thinking

Attention to detail

Communication skills

Problem solving

Multi-tasking

Regulatory knowledge

Education

Bachelor's degree in Biology, Chemistry, Medical Technology

Advanced degree or RAC preferred

Tools

SAP

Regulatory databases

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.
• Coordinateresponses to regulatory authority questions and information requests with cross-functional partners.
• Manage Regulatory Affairs change requests and maintain audit-ready records.
• Maintaintechnical 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.