Regulatory Affairs Jobs at Beckman Coulter Diagnostics USA
Looking for high-paying Regulatory Affairs Jobs in the USA with a global diagnostics leader? Beckman Coulter Diagnostics Careers now offer an exciting Analyst I Regulatory Affairs role in California with a salary range of $100,000–$120,000 per year. This is an excellent Fresher’s Job and a strong job opportunity for life science graduates seeking to enter regulatory affairs, medical devices, and IVD compliance while working with one of the most trusted names in diagnostics.
About Beckman Coulter Diagnostics
Beckman Coulter Diagnostics is a global leader in clinical diagnostics and part of the Danaher family of operating companies. For more than 90 years, the organization has delivered innovative diagnostic solutions used in hospitals, reference and research laboratories, and physician offices worldwide. More than one million tests are run every hour on Beckman Coulter Diagnostics systems, impacting over one billion patients annually.
Job Details:
- Job Title: Analyst I – Regulatory Affairs
- Company: Beckman Coulter Diagnostics (Danaher Operating Company)
- Location: West Sacramento, California, United States
- Employment Type: Full-Time
- Work Model: On-site
Regulatory Affairs Job Role Overview
The Analyst I, Regulatory Affairs supports global regulatory strategies for microbiology-based in vitro diagnostic (IVD) products, including antimicrobial susceptibility testing (AST) systems. The role focuses on ensuring compliance with U.S. FDA and EU IVDR requirements and contributes to regulatory submissions and technical documentation throughout the product lifecycle. This position reports to the Senior Director, QRC Microbiology and is part of the Regulatory Affairs team based in West Sacramento, California.
Key Responsibilities
- Assist in preparing and maintaining regulatory submissions, including 510(k) submissions and EU IVDR Technical Documentation
- Support cross-functional teams such as R&D, Clinical Affairs, and Quality to ensure regulatory compliance across the product lifecycle
- Learn, interpret, and apply FDA regulations, EU IVDR requirements, guidance documents, and applicable standards (including ISO 13485 and ISO 14971)
- Contribute to regulatory strategies for new product development and product changes
- Support responses to regulatory authority inquiries and audits
Required Qualifications
- Bachelor’s degree in microbiology, biology, biomedical engineering, or a related scientific discipline
- 0–2 years of experience in regulatory affairs or related functions within the IVD or medical device industry (internship or co-op experience acceptable)
- Basic understanding of FDA regulations (21 CFR 809, 820) and EU IVDR (2017/746)
- Strong written and verbal communication skills
- Detail-oriented with strong organizational and time management skills
Preferred Qualifications
- Familiarity with microbiology-based diagnostics or antimicrobial susceptibility testing (AST) systems
- Exposure to regulatory submissions such as 510(k) or IVDR Technical Documentation
- Regulatory Affairs Certification (RAC) or willingness to pursue certification
Compensation and Benefits of Regulatory Affairs Jobs
- Annual Salary Range: $100,000 – $120,000 USD
- Eligible for bonus and incentive pay
- Comprehensive benefits package including:
- Paid time off
- Medical, dental, and vision insurance
- 401(k) retirement plan
