Regulatory Affairs

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.

• 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.

• 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…