RA Specialist I - Temporary

Bio-Rad Laboratories; Hercules (CA); On-site; USD 44,000 - 48,000; Full time

Job summary

Bio-Rad Laboratories in Hercules, CA is seeking a Regulatory Support Associate to provide regulatory support for IVD products across multiple groups. The role assembles low to medium complexity submissions to support worldwide product registrations and coordinates with writers, regulatory specialists, and R&D, QA, Planning and Manufacturing teams.

Ideal candidates have a BS in Biology, 6 months to 2 years in IVD regulatory affairs, and MS Office proficiency.

Qualifications

• BS in Biology or related field.
• 6 months to 2 years in IVD regulatory affairs.
• Proficient with MS Office (Excel/Word/PowerPoint/Teams).
• Laboratory experience in a regulated IVD environment preferred.
• Understanding of scientific reports, risk management and Quality Systems.

Responsibilities

• Provide regulatory support for IVD products across multiple groups.
• Assemble low to medium complexity regulatory submissions for worldwide registrations.
• Coordinate with technical writers, regulatory specialists, and cross‑functional teams (R&D, QA, Planning, Manufacturing).
• Interface daily with databases and electronic systems, and manage priorities.

Skills

Regulatory collaboration

Prioritization

Communication

Education

BS in Biology

Tools

MS Office

Job description

Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support world wide product registration change requests for IVDR. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publisher, technical writers and regulatory specialists. Work collaboratively with R & D, QA, Planning and Manufacturing teams.

How You'll Make An Impact

• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
• Ability to communicate effectively with employees across multiple departments
• Highly organized and detail-oriented. Good time management.
• Technical aptitude for understanding IVD product features
• Understanding of databases and electronic systems

What You Bring

• Education:BS in Biology or other scientific field
• Work Experience: 6 mo -2 years experience in IVD regulatory affairs.
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
• Laboratory research experience in an IVD medical device regulated environment is strongly preferred.
• Understanding of scientific reports, risk management, Quality Systems

Compensation

The estimated hourly range for this position is $32.00 to $35.00 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.

Agency Non-Solicitation

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes

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