Analyst I Regulatory Affairs

Danaher Corporation•Sacramento, CA

1d•$100 - $120•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Regulatory Analyst I is responsible for supporting global regulatory strategies for microbiology-based IVD products, including antimicrobial susceptibility testing (AST) systems. This role ensures compliance with FDA and EU IVDR requirements and assists in preparing regulatory submissions and technical documentation. This position reports to the Sr. Director QRC Microbiology and is part of the Regulatory Affairs Team located in West Sacramento, CA and will be an on-site role. In this role, you will have the opportunity to: Assist in preparing and maintaining regulatory submissions (e.g., 510(k), Technical Documentation). Support cross-functional teams (R&D, Clinical Affairs, Quality) to meet regulatory requirements throughout the product lifecycle. Learn and apply FDA and IVDR regulations, guidance documents, and standards (ISO 13485, ISO 14971). Contribute to regulatory strategies for new product development and changes. Support responses to regulatory agency inquiries and audits.

Requirements

Education: Bachelor’s degree in microbiology, biology, biomedical engineering, or related scientific discipline.
Experience: 0–2 years in regulatory affairs or related functions in IVD or medical device industry (internship or co-op acceptable).
Basic understanding of FDA regulations (21 CFR 809, 820) and EU IVDR (2017/746).
Strong written and verbal communication skills.
Detail-oriented with good organizational and time management skills.

Nice To Haves

Familiarity with microbiology-based diagnostics or AST systems.
Exposure to regulatory submissions (510(k), IVDR Technical Documentation).
Regulatory Affairs Certification (RAC) or willingness to pursue.

Responsibilities

Assist in preparing and maintaining regulatory submissions (e.g., 510(k), Technical Documentation).
Support cross-functional teams (R&D, Clinical Affairs, Quality) to meet regulatory requirements throughout the product lifecycle.
Learn and apply FDA and IVDR regulations, guidance documents, and standards (ISO 13485, ISO 14971).
Contribute to regulatory strategies for new product development and changes.
Support responses to regulatory agency inquiries and audits.

Benefits

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.
Check out our benefits at Danaher Benefits Info.
The annual salary range for this role is $100-120K.
This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.
This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable.
The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.