Job Description

Job Description Summary

The Head of Regulatory Information Management is accountable for the strategy, governance, operating model and performance of the company's RIM capability, including Regulatory Data Governance. The role sets direction for RIM systems, regulatory data standards, stewardship, quality metrics and continuous improvement across Regulatory Affairs, ensuring trusted regulatory data and effective tools support compliant, scalable business processes. Operational execution, hands-on data maintenance, system administration, document processing, routine system updates and training delivery are performed by designated process owners, business administrators and data stewards under their leadership.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Responsibilities:

• 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, including Veeva RIM, Lorenz docuBridge, AMS, xEVMPD/IDMP processes and related integrations, 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 prioritisation.
• Sponsor continuous improvement and transformation initiatives that simplify processes, strengthen data integrity, improve automation and enable global work-sharing, acting as steering leader rather than day-to-day project manager.
• Ensure RIM systems, processes and data governance practices meet QMS, GDP, data integrity and regulatory expectations, and represent RIM/Data Governance in Regulatory Operations leadership, cross-functional governance and selected external/industry interactions.

Qualifications and Experience:

• 8+ years of experience in Regulatory Affairs, Regulatory Operations or Regulatory Information Management in a regulated life sciences environment, including leadership of global RIM, regulatory systems or regulatory data capabilities.
• 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.

Desirable Skills:

• Ability to influence senior stakeholders and align cross-functional teams around shared standards, governance decisions and strategic priorities.
• Experience establishing regulatory data governance, stewardship models, data quality KPIs, issue management and lifecycle controls for regulatory master data.
• Experience shaping digital and data roadmaps, vendor governance and IT-enabled transformation across Veeva Vault/RIM and related regulatory systems.
• Strong analytical, communication and change management capability, with ability to convert metrics, risks and data quality signals into strategy and effective decisions.

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Disclaimer: GE HealthCare will never ask for payment to process documents, refer you to a third party to process applications or visas, or ask you to pay costs. Never send money to anyone suggesting they can provide employment with GE HealthCare. If you suspect you have received a fraudulent call , please fill out the form below: https://www.ge.com/careers/fraud

#LI-RS1

Additional Information

Relocation Assistance Provided: No