AI Regulatory Program Manager
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: Minnesota • Wisconsin • United States
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About the role
- The AI Regulatory Program Manager is responsible in supporting regulatory submissions for AI-driven medical software and devices.
- Project management & cross-functional collaboration with clinical experts, data annotators, and arbitrators.
- Track regulatory landscape changes and support the creation and standardization of regulatory processes and documentation.
- Define validation dataset requirements, acquire, clean, and document datasets for regulatory validation.
- Perform advanced statistical analyses and prepare statistical arguments for regulatory submissions.
Requirements
- Bachelor's degree 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
- Competitive compensation
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisexperimental designdata managementAI/ML model validationperformance metricsregulatory submissionsdataset requirementsdata cleaningadvanced statistical analyses
Soft Skills
written communicationverbal communicationproject managementcross-functional collaborationcontext-switchingability to manage multiple projects
Certifications
Bachelor's degree in StatisticsBachelor's degree in Biomedical Engineering