Head of Regulatory Information Management

🔥 13 minutes ago

🇺🇸 United States – Remote

💵 $122.4k - $183.6k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• 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

• 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

• medical • dental • vision • paid time off • a 401(k) plan with employee and company contribution opportunities • life insurance • disability insurance • accident insurance • tuition reimbursement