RA Specialist IV

Join us in shaping the future of diagnostics! In this role, you’ll provide regulatory expertise on CLIA regulations and guide Laboratory Developed Test (LDT) development, while supporting Research Use Only (RUO) products. You’ll prepare complex global submissions, secure import permits, and resolve change requests with strong analytical and communication skills. Collaborating with Marketing, R&D, QA, and Manufacturing, you’ll ensure compliance for product launches and review advertising materials for CLIA labs. Your work will drive innovation and global impact every day.

How You’ll Make An Impact: 

• Technical aptitude for understanding RUO products targeted toward cancer or other LDTs in a CLIA laboratory. 
• Understand how to develop and maintain compliance programs for CLIA-certified labs. 
• Experience with adherence to CLIA, CAP, and state regulations for high-complexity testing. 
• Support validation and verification programs of LDTs. 
• Experience with regulatory requirements for advertising for RUO products in CLIA laboratory. 
• Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines for projects. 
• Provide timely and accurate regulatory submissions for worldwide country submissions.

What You Bring:

• Education:BS in Biology or other scientific field. Advanced degree (e.g. Master’s or Ph.D.) is not mandatory but strongly encouraged. 
• Work Experience: 5-10 years experience in clinical laboratory with understanding of ClIA regulations and development of laboratory developed tests. 
• Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams) 
• Laboratory research experience in an CLIA-certified laboratory. 
• Experience with advertising in a CLIA-certified laboratory environment. 
• Understanding of scientific reports, risk management, clinical studies & Quality Systems.

Total Rewards Package: At Bio-Rad, we’re empowered by our purpose and recognize that our employees are as well. That’s why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

Benefits: We’re proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability,  paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG’s), and more! 

Compensation: The estimated base salary range for this position is $117,900 to $162,200 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. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

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.

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