Head of Regulatory Information Management

Reposted 10 Hours Ago
Be an Early Applicant
Hiring Remotely in USA
Remote
122K-184K Annually
Senior level
Artificial Intelligence • Healthtech • Analytics • Biotech
The Role
Lead strategy, governance and operating model for Regulatory Information Management (RIM). Own RIM systems, data governance, standards, KPIs and continuous improvement. Build and lead the RIM team, chair governance forums, set priorities for Veeva/Lorenz/IDMP processes, ensure compliance with QMS/GxP/GDP, and sponsor transformation while delegating day-to-day execution to administrators and data stewards.
Summary Generated by Built In
Job Description SummaryThe 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

Roles and 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 worksharing, 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.

Required Qualifications

  • 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.

Desired Characteristics

  • 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.

Other Requirements

  • 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%

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $122,400.00-$183,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: August 28, 2026

Skills Required

  • 8+ years experience in Regulatory Affairs, Regulatory Operations or Regulatory Information Management in a regulated life sciences environment, including leadership of global RIM or regulatory systems/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, IDMP/xEVMPD expectations and global registration/submission lifecycle processes.
  • Proficiency in spoken and written English.
  • Willingness to attend local GE HealthCare office as-needed.
  • Willingness to travel when required (not more than 5-10%).
  • Legal authorization to work in the United States (employer will not sponsor visas).
  • Successful completion of a drug screen as applicable.
  • Ability to influence senior stakeholders and align cross-functional teams around standards and governance decisions.
  • 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.

GE Healthcare Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.

  • Healthcare Strength Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
  • Retirement Support Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
  • Strong & Reliable Incentives Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.

GE Healthcare Insights

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The Company
HQ: Chicago, IL
50,282 Employees
Year Founded: 1892

What We Do

Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.

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