Sr. Software Engineer - AI Regulatory

**Job Description Summary

We are seeking an AI Regulatory Engineer to bridge AI development, systems engineering, clinical workflow, quality systems, and regulatory requirements for AI-enabled medical devices.

The role will work directly with AI and product engineering teams to assess regulatory impact, build compliant technical evidence, and support efficient and scalable AI product registrations. The ideal candidate combines strong technical understanding with regulatory, quality, and risk-management knowledge.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Roles and Responsibilities

• Regulatory Impact Assessment: Evaluate how changes to AI models, datasets, intended use, clinical workflows, and product claims affect regulatory strategy, verification and validation, risk management, and QMS activities.
• Technical & Regulatory Analysis: Work directly with AI teams to understand feature design, model assumptions, failure modes, dataset strategy, and validation evidence, and translate technical decisions into clear regulatory rationale.
• AI Registration Support: Develop and review technical evidence required for AI product registrations and submissions, including requirements, risk analysis, verification/validation, performance evaluation, and supporting documentation.
• Regulatory Deficiency Response: Lead the technical analysis and coordination of responses to questions or deficiencies from regulatory authorities such as NMPA and FDA, identifying required evidence or additional testing before escalation to AI subject-matter experts.
• Traceability & Compliance: Maintain clear traceability among product requirements, design decisions, datasets, AI models, risk controls, verification evidence, and regulatory claims.
• Cross-functional Partnership: Collaborate with AI Engineering, Systems Engineering, Clinical, Quality, Regulatory Affairs, and other functions to identify regulatory risks early and drive them to resolution.

Qualifications

• Master's degree or above in Biomedical Engineering, Computer Science, Medical Imaging, AI/ML, Software Engineering, or a related technical field.

• Strong understanding of AI/ML concepts and the ability to engage directly with AI engineers on model design, datasets, performance, and technical risks.

• Experience in one or more of the following areas:

• Medical device development or Software as a Medical Device (SaMD)

• AI/ML-enabled medical devices

• FDA and/or NMPA submissions

• Systems engineering

• Verification and validation

• Medical-device quality and risk management

• Strong analytical skills with the ability to independently evaluate technical issues and develop regulatory rationale.

• Strong technical writing, problem-solving, and cross-functional communication skills.

• Preferred Qualifications

• Experience with medical imaging or healthcare AI products.

• Experience preparing or supporting regulatory submissions for AI-enabled medical devices.

• Familiarity with medical-device design controls, software lifecycle, risk management, verification/validation, and AI performance evaluation.

• Hands-on experience assessing the regulatory impact of changes to AI models, datasets, workflows, intended use, or product claims.

Positioning statement:

• This is not primarily a regulatory documentation role. The AI Regulatory Engineer is expected to be a technical contributor who can independently analyze AI product changes, identify their quality and regulatory implications, and work with engineering teams to develop the evidence needed for successful product registration.

• Inclusion and Diversity

• GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

• We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

• Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support

Additional Information

Relocation Assistance Provided: **No