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Head of Regulatory Information Management
GE HealthCareHead of Regulatory Information Management at GE HealthCare managing the RIM capability and governance. Overseeing regulatory data standards, stewardship, and continuous improvement initiatives.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Information Management (RIM) strategy and governance, with a strong focus on data quality, compliance, and team leadership in a regulated life sciences environment. Proven ability to drive continuous improvement initiatives and manage cross-functional teams effectively.
Highest-signal resume keywords
Regulatory Affairs ExperienceRegulatory Information Management (RIM)Data Governance FrameworkPeople LeadershipRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Data GovernanceData Quality ManagementChange ControlPerformance ManagementBudget PlanningResource PlanningCapability DevelopmentRegulatory ComplianceIDMP/xEVMPD ExpectationsGlobal Registration Processes
Soft Skills
Team LeadershipChange LeadershipInclusive Culture BuildingCross-Functional CollaborationCommunication
Industry Keywords
Life SciencesQMSGxPGDPRegulatory OperationsRegulatory Master DataCAPARisk-Based ImprovementsOperational ExecutionMatrix Environment
About the role
Key responsibilities & impact- Own and lead the RIM strategy, roadmap and target operating model, aligned to Regulatory Affairs, Regulatory Operations, Quality and enterprise data and digital priorities
- Lead and develop the RIM team, including recruitment, onboarding, capability building, succession planning and performance management, while fostering an inclusive and accountable team culture
- Establish and chair RIM and Regulatory Data Governance forums to align priorities, make cross-functional decisions, resolve escalations and maintain clear ownership of systems, processes and data
- Own the Regulatory Data Governance framework, including data ownership and stewardship, data standards, data quality thresholds, KPIs, issue escalation and lifecycle controls for regulatory master data
- Set strategic business ownership and governance for the RIM ecosystem, ensuring investment and release priorities support business needs
- Define the resource and operating model needed for sustainable delivery and resilience, delegating operational execution to designated business administrators, process owners and data stewards
- Monitor RIM, regulatory data quality and process performance metrics, using insights to drive risk-based improvements, CAPA effectiveness, leadership decisions and prioritization
- Sponsor continuous improvement and transformation initiatives that simplify processes, strengthen data integrity, improve automation and enable global worksharing.
Requirements
What you’ll need- 8+ years of experience in Regulatory Affairs, Regulatory Operations or Regulatory Information Management in a regulated life sciences environment
- Demonstrated people leadership and strategic operating model experience, including budget and resource planning, performance management, capability development and change leadership in a matrix environment
- Strong understanding of RIM business applications and regulatory data governance, QMS/GxP/GDP, change control, data integrity, regulatory compliance, IDMP/xEVMPD expectations and global registration/submission lifecycle processes
- Proficiency in spoken and written English
- Willing to attend local GE HealthCare office on an as-needed basis
- Willing to travel when required, but not more than 5-10%
Benefits
Comp & perks- medical
- dental
- vision
- paid time off
- a 401(k) plan with employee and company contribution opportunities
- life insurance
- disability insurance
- accident insurance
- tuition reimbursement