Regulatory Jobs
Hero Gradient Background
Aldevron's Breakthrough manufacturing campus in Fargo, North Dakota, lit up at dusk
Danaher logo

New · posted Nov 6

Danaher · Medical Devices

Staff Regulatory Affairs

  • Remote, US
  • Remote
  • Full-time
  • Senior & Principal
Save
Pay$116K
EmploymentFull-time
LocationRemote, US
LevelSenior & Principal
FunctionRegulatory Strategy
DeadlineOpen until filled

The role

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.

What you need

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.

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.

Join our winning team today. 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.

The U.S. EEO posters are available here.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

Skills named in this posting

What you'll do

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.

Pay and benefits

$116,000 a year

Employer provided
How this compares

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.

  • Paid time off

  • Medical/dental/vision insurance

  • 401(k)

  • Bonus/incentive pay

  • Remote work arrangement

Equal opportunity, accessibility and legal noticesDanaher's statements, word for word

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.

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 [email protected].

Job intelligence

The context around this role

Live data · November 6, 2026

Salary intelligence

How the pay compares

This role's midpoint is 27% below the US median for Regulatory Strategy roles at this level.

This roleEmployer provided

$116,000 to $116,000 a year

Senior & Principal roles in the US6 roles publishing pay

Middle half $150,000 to $174,750, median $159,750
Annual base pay
Annual base payLowMedianHigh
This role$116,000—$116,000
All US$150,000$159,750$174,750

This role: Danaher's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Regulatory Strategy

The general path across 89 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Associate Consultant, Regulatory Science and Strategy · Spring 2027 Co-op, Global Regulatory Affairs

    2 open

  2. This role

    Senior & Principal

    Often: Principal Regulatory Affairs Specialist · Regulatory Affairs Strategist, Globalization

    $160K median10 open

  3. Next step

    Manager

    Often: Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada · Manager, Regulatory Affairs Strategy

    $160K median21 open

  4. Later

    Director

    Often: Director, RA Global Regulatory Strategy · Associate Director, Regulatory Affairs Strategy

    $252K median48 open

  5. Later

    VP & Executive

    Often: Global Head of Injectable Aesthetics Regulatory Strategy · Global Head of Technical Regulatory & Quality

    $333K median8 open

Career resources on Regulatory Strategy

Skills DNA

What this role leans on

How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 2 linesLab testing and methods: 2 linesDocumentation and SOPs: 2 linesValidation and qualification: 1 lineRegulatory submissions: 3 linesQuality systems and risk: 3 linesData and digital systems: 2 linesCollaboration and leadership: 8 linesGMPLab testingDocumentationValidationSubmissionsQuality systemsData systemsTeamwork
  • Collaboration and leadership8
  • Regulatory submissions3
  • Quality systems and risk3
  • GMP and compliance2
  • Lab testing and methods2
  • Documentation and SOPs2
  • Data and digital systems2
  • Validation and qualification1

Regulatory intelligence

The rules, regulations and standards behind this role

The regulations, guidance and standards that govern Regulatory Strategy work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Danaher on Regulatory Jobs

60
Open roles
60
Distinct roles
20
Locations

By discipline

  • Quality50 82%
  • Regulatory8 13%
  • Clinical3 5%

By level

  • Senior & Principal29 48%
  • Associate & Specialist22 36%
  • Manager8 13%
See all 60 Danaher roles

More roles at Danaher

All 60 Danaher roles

Similar Regulatory Strategy roles elsewhere

Staff Regulatory Affairs at Danaher

Open until filled. $116K a year, employer provided.

Job alerts