Staff Global Regulatory GPO

Danaher; Chaska (MN); Remote; USD 140,000 - 170,000; Full time

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Global Regulatory Affairs professional. You will develop and execute global regulatory strategies, manage lifecycle tools, and ensure labeling and MAPSS content meet worldwide requirements.

This role emphasizes cross-functional collaboration and strong stakeholder communication. Remote-friendly with potential on-site flexibility, the position reports to Global Compliance leadership and offers a competitive salary and

Qualifications

• Bachelor’s degree in a relevant field.
• 9+ years experience in regulatory affairs, or 7+ with a Master, or 4+ with a PhD.
• Critically review global regulations and assess impact to products and processes.
• Develop clear written assessments and stakeholder-ready presentations.
• Microsoft Office proficiency.

Responsibilities

• Develop and execute global regulatory strategies to ensure worldwide compliance.
• Manage, maintain and optimize tools and workflows for regulatory lifecycle.
• Develop and manage global regulatory labeling requirements and procedures.
• Oversee MAPSS content to align with regulatory requirements.
• Partner with BU Regulatory Affairs and Commercial Regulatory teams.

Skills

Regulatory strategy

Global compliance

Written communication

MS Office

Education

Bachelor's degree in applicable field

Master's degree in applicable field

Doctoral degree in applicable field

Tools

Microsoft Office Suite

Job description

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.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• 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)

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

• 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.

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.

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For more information, visit www.danaher.com.

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The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

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 (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

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].