Key Facts

Remote From:

United States

Category: Platform Manager

Full time

Senior (5-10 years)

175 - 175K yearly

English

Hard Skills

AI/ML Inference Process Improvement Business Analysis Title 47 CFR Part 15 Computer System Validation Digital Transformation Platform Design And Development FDA Regulations Computational Tools Test Automation

Other Skills

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Communication
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Teamwork
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Problem Solving

Roles & Responsibilities

Bachelor's degree with 14+ years of experience, or Master's/Doctoral degree with 12+ years of experience in a regulated industry environment
Demonstrated experience as a Business Analyst or Systems Process Owner within Quality or Regulatory Affairs functions
Strong understanding of GxP, 21 CFR Part 11, and CSV/computer systems validation principles
Experience leading cross-functional digital transformation or platform implementation initiatives in a regulated industry environment

Requirements:

Act as the strategic process and platform owner for the RIMS platform, ensuring global process alignment while embedding AI capabilities
Harmonize regulatory processes across the various Operating Companies of Danaher Diagnostics
Own the full platform lifecycle for RIMS - from requirements and configuration through validation, deployment, and continuous improvement
Manage the validated state of the RIMS platform, ensuring all changes meet regulatory, data integrity, and CSV standards

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 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 Sr. Staff RIMS Platform Owner for Danaher Diagnostics is responsible for end-to-end process and technology ownership, governance, and continuous evolution of the Regulatory Information Management System platform across the Regulatory Affairs organization. This role serves as the strategic link between Regulatory Affairs, IT, and external platform vendors — actively integrating AI capabilities and intelligent agents to modernize and accelerate regulatory workflows.

This position reports to the Sr. Manager, Innovation DBSL and AI and is part of the Quality, Regulatory, and Clinical Affairs (QRC) organization. There is a preference for candidates who can work on-site in Brea, CA, Sacramento, CA or Chaska, MN sites. While this req is posted as on-site in the US, applications from qualified candidates in other US locations will be considered equally for a remote role.

In this role, you will have the opportunity to:

Act as the strategic process and platform owner for the RIMS platform, ensuring global process alignment while embedding AI capabilities and intelligent agents to automate workflows and surface actionable insights.
Harmonize regulatory processes across the various Operating Companies (OpCos) of Danaher Diagnostics to ensure RIMS software and workflows function seamlessly and consistently across the diverse business landscape.
Own the full platform lifecycle for RIMS — from requirements and configuration through validation, deployment, and continuous improvement — serving as the single accountable owner across all connected regulatory tools.
Manage the validated state of the RIMS platform, ensuring all changes, integrations, and new capabilities meet regulatory, data integrity, and computer systems validation standards.
Define and execute the RIMS platform roadmap, enabling a connected regulatory digital thread across systems such as MasterControl, Veeva, Regdesk, MAPPS, and adjacent quality and submission platforms.

The essential requirements of the job include:

Bachelor's degree with 14+ years of experience, or Master's/Doctoral degree with 12+ years of experience in a regulated industry environment.
Demonstrated experience as a Business Analyst or Systems Process Owner within Quality or Regulatory Affairs functions.
Working knowledge of eQMS and/or RIMS platforms (e.g., SmartSolve, MasterControl, Veeva, Regdesk, or equivalent).
Strong understanding of GxP, 21 CFR Part 11, and CSV/computer systems validation principles.
Experience leading cross-functional digital transformation or platform implementation initiatives in a regulated industry environment.

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

FDA-regulated diagnostics or medical device industry, including hands-on RIMS platform rollouts across multiple Operating Companies or business units.
Familiarity with AI or automation tools, including custom-built AI systems and agents, being integrated into QRC workflows, preferably within a Danaher Business System (DBS) environment.

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.

The annual salary range for this role is 165 - 175K USD. 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.

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.

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.

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.

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 applyassistance@danaher.com.

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