Staff Global Regulatory GPO

About Us

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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Job Summary

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](https://danaher.com/our-businesses) 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](https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The _Staff Global Regulatory Affairs_ ensures that Beckman Coulter products, processes, and documentation adhere to global premarket regulations for registration lifecycle management, global labeling requirements and marketing material review and approval procedures.

This position reports to the **_Director of Global Compliance and Regulatory Affairs_** and is part of the **_Global Regulatory Affairs Department_** and will be fully remote.

Responsibilities

• Develop, implement and execute global regulatory strategies to ensure worldwide compliance through standardized processes and procedures and support internal and external audits and regulatory inspections.
• Manage, maintain and optimize tools and workflows used to manage the product regulatory lifecycle.
• Develop and manage BEC global regulatory product labeling requirements and procedures.
• Manage the regulatory requirements for the content of marketing, advertising, promotional, and sales product training and scientific material (MAPSS) and ensure global registration activities align with applicable regulatory requirements.
• Build strong partnerships with Business Unit Regulatory Affairs and Commercial Regulatory Affairs teams, sharing best practices and driving cross-functional initiatives.

Requirements

• Bachelor’s degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 9+ years of related work experience OR Master's degree in applicable field with 7+ years of related work experience OR Doctoral degree in applicable field with 4+ years of related work experience
• Critically review global regulations and evaluate applicability and impact to BEC products and processes.
• Develop clear written assessments and stakeholder-ready presentations to communicate regulatory requirements and recommendations.
• Microsoft tool proficiency

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to periodically travel to the US (minimum once a year)

Preferred Qualifications

• Prior experience with in-vitro diagnostic devices or other regulated industries.
• Leads effectively in matrixed and cross-cultural environments, driving timely decisions, issue resolution, and resource agility while setting high expectations and modeling accountability and integrity.
• Communicates complex and sensitive information clearly across diverse audiences; builds consensus, demonstrates strong writing and documentation skills, and uses sound judgment to influence and lead through change.

Benefits

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](https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home).

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. While this position is preferred to be on-site, it 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 $140,000 - 170,000. 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 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.