AI Regulatory Program Manager
GE HealthCare
full-time
Posted on:
Location Type: Hybrid
Location: Waukesha • Minnesota • Wisconsin • United States
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisexperimental designdata managementregulatory submissionsAI/ML model validationpower calculationsWilcoxon Ranked Sign TestBland-Altmandata cleaningvalidation dataset requirements
Soft Skills
written communicationverbal communicationproject managementcross-functional collaborationcontext-switchingorganizational skillsattention to detailproblem-solvingadaptabilitytechnical justification
Certifications
MS in StatisticsPhD in StatisticsBiomedical Engineering