Staff Regulatory Affairs

Beckman Coulter Diagnostics; Miami (FL); Remote; USD 116,000 - 150,000; Full time

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Regulatory Affairs professional to shape regulatory strategies and expand global markets for IVDs and medical devices.

You will partner with senior leadership to lead registrations and submissions across the US, EU, and international markets, while mentoring colleagues in a fully remote role from the Miami area.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biology, Chemistry, Biomedical Engineering, Medical Technology, Clinical Laboratory Science, or related field.
• 8+ years of regulatory affairs experience supporting medical devices and/or IVDs.
• Expertise in U.S. FDA and EU IVDR regulatory requirements, including lifecycle management and labeling.
• Strong ability to evaluate data, study design, risk assessments and documentation for regulatory decisions.
• Ability to travel up to 10% (overnight) domestically and internationally.

Responsibilities

• Develop regulatory strategies to accelerate innovation and global market access for IVDs and medical devices.
• Assess complex data and study designs to provide clear regulatory recommendations.
• Partner across functions to implement compliant product and process changes throughout the lifecycle.
• Lead regulatory activities for registrations, approvals, and ongoing market access worldwide.
• Mentor colleagues and drive continuous improvement within the regulatory team.

Skills

Regulatory affairs

FDA IVDR

Product lifecycle management

Regulatory submissions

Cross-functional collaboration

Change assessments

Data evaluation

Travel readiness

Education

Bachelor's degree in regulatory or science field

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

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.

In This Role, You Will Have The Opportunity To

• 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.

The Essential Requirements Of The Job Include

• 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

It would be a plus if you also possess previous experience in:

• 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. Check out our benefits at Danaher Benefits Info. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. 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. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

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.

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].