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.
