AI Regulatory Engineer

We are seeking a proactive and detail-orientedAI Regulatory Engineerto ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirementsparticularly FDA regulations for AI-enabled medical devices.


This role is critical as AI has become a highly regulated domain requiring specialized regulatory strategies risk management approaches and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering clinical quality product management and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.

Key Responsibilities

AI Regulatory Strategy & Compliance

Interpret and apply regulatory frameworks and guidance forAI-enabled medical devices including FDA EU MDR/IVDR and global regulations.

Define and driveAI regulatory strategiesfor clinical ultrasound features including SaMD and AI-enabled device functions.

Support FDA submission pathways (e.g. 510(k) De Novo PMA) for AI-based features includingAI-specific regulatory positioning.

Risk Management & Safety for AI

Lead AI-focused risk management activities in accordance withISO 14971 addressing AI-specific hazards such as bias robustness generalization risk and clinical misuse.

Perform and maintain AI-specific risk analyses (e.g. AI FMEA algorithm hazard analysis clinical performance risk).

Ensure traceability between clinical requirements AI behavior risk controls and verification/validation evidence.

Regulatory Documentation & Submissions

Prepare and maintain AI-related regulatory documentation including:

AIdescriptions and intended use statements

Training and validation datasetdescriptions

Performance evaluation and clinical evidence summaries

Algorithm change management and lifecycle documentation

Support creation ofFDA-ready AI documentation including transparency explainability and human-factors considerations.

AI Lifecycle & Change Management

Define regulatory-compliant processes forAI updates retraining and post-market changes aligned with FDA expectations.

Support implementation ofPredetermined Change Control Plans (PCCP)or equivalent AI lifecycle strategies.

Ensure alignment between AI development practices and regulatory expectations for locked vs. adaptive algorithms.

Cross-Functional Collaboration

Collaborate closely with:

AI engineers and data scientists

Clinical and medical affairs teams

Quality systems and V&V engineers

Product management and regulatory affairs

Embed regulatory and safety requirements early into AI design data strategy and clinical validation plans.

Regulatory Intelligence & Audits

Monitor evolving AI regulations FDA guidance standards and industry best practices.

Communicate regulatory changes and their impact on AI roadmaps and product strategy.

Support internal audits design reviews and external regulatory inspections related to AI and clinical safety.

Provide training and guidance onAI regulatory and safety topicsto engineering and product teams.

Qualifications

Required Qualifications

Bachelors or Masters degree in Engineering Computer Science Biomedical Engineering or related field.

Experience working inregulated medical device environments preferably involving AI-driven clinical features.

Solid understanding ofmedical device regulatory frameworks with emphasis on FDA and EU MDR.

Experience withrisk management methodologiesand safety processes for medical devices.

Strong analytical documentation and communication skills.

Ability to work independently and collaboratively in a multidisciplinary environment.

Preferred Qualifications

Experience withAI-enabled medical devices SaMD or clinical decision support systems.

Familiarity with FDA guidance onAI in medical devices Good AI Practice and AI lifecycle governance.

Experience supporting FDA submissions involving software or AI components.

Knowledge of AI-related topics such as dataset governance algorithm performance metrics bias mitigation and explainability.

Certification or formal training in regulatory affairs quality or safety (e.g. RAC TÜV ASQ).

Experience working with global regulatory regions (US EU Asia).

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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.

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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.

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Relocation Assistance Provided: No