Sr. Staff RIMS Platform Owner

Danaher•Round Rock, TX

15h•$165,000 - $175,000•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.