AI Regulatory Program Manager

GE HealthCare • Waukesha, WI

15h

About The Position

The AI Regulatory Program Manager is responsible in supporting regulatory submissions for AI-driven medical software and devices within the General Imaging and Primary Care Business. This position bridges engineering, regulatory affairs, and biostatistics, ensuring that validation studies, data analysis, and regulatory documentation meet the highest standards required by global agencies (FDA, NMPA, etc.). The ideal candidate will leverage their expertise and collaborate with GEHC regulatory affairs and Biostatisticians to design, analyze, and justify validation datasets and metrics, while streamlining regulatory processes for the product engineering team

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).

Nice To Haves

• 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.

Responsibilities

• Project Management & Cross-functional Collaboration 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.
• Regulatory Study Design & Data Management 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.
• Statistical Analysis 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.
• Regulatory Documentation & Submission 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees