GE HealthCare · 23 hours ago
AI Regulatory Program Manager
Waukesha, WI
Full-time
Onsite
Mid, Senior LevelGE HealthCare is seeking an AI Regulatory Program Manager to support regulatory submissions for AI-driven medical software and devices. The role involves coordinating with cross-functional teams, managing regulatory processes, and performing statistical analyses to ensure compliance with global regulatory standards.
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No H1B
Responsibilities
Coordinate with clinical experts, data annotators, and arbitrators to ensure validation studies meet regulatory standards
Track regulatory landscape changes and update processes accordingly
Support the creation and standardization of regulatory processes and documentation for future teams
Define validation dataset requirements (size, demographics, sites) in compliance with regulatory guidance
Acquire, clean, and document datasets for regulatory validation, ensuring data integrity and traceability
Design and oversee regulatory test plans and procedures, including dry runs and iterative improvements
Design and develop reader study experiments in collaboration with GEHC regulatory and research teams
Organize and index validation data and metadata for efficient analysis and reporting
Perform advanced statistical analyses (e.g., power calculations, Wilcoxon Ranked Sign Test, Bland-Altman etc.) to justify dataset size and model performance
Generate and interpret statistics from reader studies and other validation experiments
Prepare statistical arguments and documentation for regulatory submissions, addressing agency feedback and deficiency letters
Write and review regulatory reports (e.g., FDA 510k, NMPA) with a focus on statistical rigor and clarity
Collaborate with engineering and regulatory affairs to ensure alignment with the latest regulatory requirements and best practices
Respond to regulatory agency feedback, providing statistical and technical justifications as needed
Qualification
Required
Advanced degree (MS/PhD) in Statistics, Biomedical Engineering, or related field
Experience in regulatory submissions for medical devices or software (FDA, NMPA, or similar)
Strong proficiency in statistical analysis, experimental design, and data management
Familiarity with AI/ML model validation and performance metrics
Excellent written and verbal communication skills, especially in technical and regulatory documentation
Ability to manage multiple projects and context-switch efficiently in a fast-paced environment
Experience working with cross-functional teams (engineering, clinical, regulatory)
Preferred
Experience with regulatory test planning and reader studies
Knowledge of medical imaging data formats and annotation tools (e.g., V7)
Project management experience in a regulated environment
Familiarity with regulatory feedback cycles and deficiency response processes
Benefits
Great work environment
Professional development
Challenging careers
Competitive compensation
Company
GE HealthCare
GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.
Founded in 1892
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.52BKey Investors
Bill & Melinda Gates Foundation
2024-11-07Post Ipo Secondary· $1.17B
2024-09-12Post Ipo Secondary· $1.29B
2024-02-16Post Ipo Secondary· $1.07B
Leadership Team
Catherine Estrampes
President and CEO, US & Canada
Luiz Verzegnassi
President & CEO, Services
Recent News
2026-01-16
Medical Device Network
2026-01-16
2026-01-16
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