[Hiring] Staff Regulatory Affairs @Danaher Corporation

Role Description

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.

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.

Requirements

• 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.

Benefits

• Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
• This position is eligible for a remote work arrangement.
• Annual salary range for this role is $116,000 - $150,000.
• This job is also eligible for bonus/incentive pay.