Staff Regulatory Affairs

Beckman Coulter, Inc.; United States; Remote; USD 116,000 - 150,000; Full time

Benefits offered by this job

Remote work arrangement

Benefits package including medical/dol

401(k)

Job summary

Beckman Coulter Diagnostics, a Danaher company, seeks a Staff Regulatory Affairs professional to shape regulatory strategies for US, EU and global markets.

You will analyze data, study designs, labeling and design changes to drive regulatory decisions, lead submissions, and mentor teams in a fast-paced diagnostics environment.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biology, Chemistry or related field required.
• 8+ years of regulatory affairs experience for medical devices and/or IVDs.
• Experience with FDA and EU IVDR regulatory requirements and submissions.

Responsibilities

• Develop and implement regulatory strategies for US, EU and global markets.
• Assess data, study designs and changes to support regulatory decisions.
• Collaborate across functions to ensure compliant product lifecycle changes.
• Lead activities for registrations, approvals and market access worldwide.
• Mentor colleagues and drive continuous regulatory improvement.

Skills

Regulatory Strategy

FDA & EU IVDR

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in Regulatory Affairs or related field

Tools

Regulatory submissions software

Job description

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 Staff Regulatory Affairs is responsible for partnering with senior leadership and cross‑functional stakeholders to shape regulatory strategies that support long‑term business objectives and global market expansion. Applies advanced scientific judgment and regulatory expertise to evaluate product performance data, study designs, manufacturing and design changes, and emerging regulatory requirements, driving decisions that protect compliance while maximizing patient, customer, and business outcomes. This position reports to the Director of Regulatory Affairs for Hematology and Urinalysis and is part of the HemeUA Regulatory Affairs team located in Miami FL and US remote. This position will be fully remote.

Key Responsibilities

• Develop and execute regulatory strategies that accelerate innovation and support the successful commercialization of IVD products in the United States, European Union, and global markets.
• Apply scientific and regulatory expertise to assess complex data, study designs, and product changes, providing clear recommendations that influence critical business and development decisions.
• Partner across functions to drive compliant and efficient implementation of product, process, software, and manufacturing changes throughout the product lifecycle.
• Lead regulatory activities for high‑impact projects, ensuring timely registrations, regulatory approvals, and sustained market access worldwide.
• Strengthen organizational capability by collaborating and mentoring colleagues, driving continuous improvement initiatives, and serving as a recognized regulatory expert for complex technical and global regulatory challenges.

Essential Qualifications

• Bachelor's degree in Regulatory Affairs, Biology, Chemistry, Biomedical Engineering, Medical Technology, Clinical Laboratory Science, or a related scientific discipline.
• 8+ years of regulatory affairs experience supporting medical devices and/or in vitro diagnostics (IVDs), including responsibility for product registrations, design changes, and regulatory submissions.
• Demonstrated expertise in U.S. FDA and European Union IVDR regulatory requirements, including product lifecycle management, change assessments, labeling, and registration activities.
• Strong technical and scientific evaluation skills, with the ability to critically assess verification and validation data, clinical and performance study design and data, risk assessments, and technical documentation to determine regulatory impact and support regulatory decision‑making.
• Proven ability to evaluate product, process, software, manufacturing, and design changes and determine resulting regulatory strategies, submission requirements, and compliance obligations while effectively influencing cross‑functional stakeholders.
• Ability to travel – up to 10% travel, overnight, within US and internationally.

Preferred Qualifications

• Experience obtaining and maintaining regulatory registrations in global markets including Canada, UK, Australia, Japan, China, Brazil, or other international jurisdictions.
• Advanced degree (M.S., Ph.D., RAC, or equivalent) in a scientific, engineering, or regulatory discipline or clinical (CLIA) lab experience.
• Regulatory or clinical lab experience in Hematology and/or Urinalysis.

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. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team.

The annual salary range for this role is $116,0000 - $150,000. 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.

Together, we’ll accelerate the real‑life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or [e-mail].

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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