Hybrid AI Regulatory Program Manager

at GE HealthCare

• Job title: AI Regulatory Program Manager
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Waukesha, United States

About the role

• AI Regulatory Program Manager responsible for supporting regulatory submissions for AI-driven medical software and devices. Collaborating across teams to ensure compliance and streamline regulatory processes.

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.

Requirements

• 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).

Benefits

• Health insurance
• Professional development
• Competitive compensation