Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

As a Regulatory Affairs Specialist III, you will execute global strategies and submissions to obtain market authorization for new products and modifications. The position partners cross‑functionally with R&D, Quality Marketing, RA Operations, and regional regulatory teams to ensure timely and compliant global registrations. Conduct thorough reviews of product data packages (e.g. analytical performance, stability, clinical performance, traceability data for controls) in accordance with applicable global regulatory requirements and regional authority standards.

This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

• Conduct thorough reviews of product data packages (e.g., analytical performance, stability, clinical performance, traceability data for controls) in accordance with applicable global regulatory requirements and regional authority standards.
• Perform regulatory gap assessments to identify additional studies, testing, or documentation required to support market authorization in target countries.
• Confirm that quality control product claims are appropriately substantiated with supporting data consistent with relevant international regulations and guidance for control materials.
• Prepare and compile global registration dossiers in collaboration with regional Regulatory Affairs teams, ensuring inclusion of all required technical documentation, quality management system certifications, and applicable testing reports.
• Review labeling and Instructions for Use (IFUs) to ensure compliance, formatting, and content requirements in accordance with applicable regulatory authorities.
• Prepare and coordinate timely responses to regulatory authority questions, deficiency letters, and supplemental information requests in partnership with cross‑functional teams.
• Manage and support multiple new and modified product registrations across global markets simultaneously, ensuring alignment with business timelines and regulatory strategies.

• 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 compliance, with experience in the medical device industry preferred (IVD experience strongly desired).
• Bilingual in Chinese (Mandarin) and English preferred, with the ability to review regulatory documents, labeling, and correspondence in both languages.
• Extensive knowledge of global regulatory requirements, including FDA, NPMA and IVDR.
• 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 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.

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.

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…