RA Specialist III - 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 is looking for a Regulatory Affairs Specialist III - Temporary 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'll 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

Compensation

The estimated hourly range for this position is $60 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.

Who We Are:

For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement:

Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

Legal Entity: (USA_1000)Bio-Rad Laboratories, Inc.