AI/ML Regulatory Engineer

GE HealthCare · Seongnam-si

Job Description Summary

We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements, particularly 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.

Job Description

[HR Talk]

GE헬스케어 성남 초음파 연구소에서 AI기반 의료기기의 Safety & Regulatory를 담당할분을 채용합니다. AI 의료기기의 Rist management, FDA/EU MDR 규제대응 및 Lifecycle Management를 담당하며 Data Science, Clinical, Quality 등 다양한 글로벌 팀과 협업하여 안전하고 신뢰할 수 있는 AI 의료기기 개발을 지원하는 역할입니다. 의료기기의 SW Reguratory 업무경험이 있으신 후보자를 우대하며 글로벌팀과의 협업이 많아 영어커뮤니케이션이 원활하신 후보자를 선호합니다.

Risk Management & Safety for AI

• Lead AI-focused risk management activities in accordance with ISO 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:

• AI descriptions and intended use statements

• Training and validation dataset descriptions

• Performance evaluation and clinical evidence summaries

• Algorithm change management and lifecycle documentation

• Support creation of FDA-ready AI documentation, including transparency, explainability, and human-factors considerations.

AI Lifecycle & Change Management

• Define regulatory-compliant processes for AI updates, retraining, and post-market changes, aligned with FDA expectations.

• Support implementation of Predetermined 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 on AI regulatory and safety topics to engineering and product teams.

Qualifications:

Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.
Experience working in regulated medical device environments, preferably involving AI-driven clinical features.
Solid understanding of medical device regulatory frameworks, with emphasis on FDA and EU MDR.
Experience with risk management methodologies and safety processes for medical devices.
Strong analytical, documentation, and communication skills.
Ability to work independently and collaboratively in a multidisciplinary environment.

Preferred Qualifications:

Experience with AI-enabled medical devices, SaMD, or clinical decision support systems.
Familiarity with FDA guidance on AI 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).

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.

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Additional Information

Relocation Assistance Provided: No

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