Job Description Summary

This position provides global regulatory strategy for Software as a Medical Device (SaMD), including cloud-based software platforms, AI/ML-enabled technologies, and digital health solutions. The role supports product development, integration, product launch, premarket submissions/registrations, and post-market compliance, working closely with global regulatory authorities, cross-functional teams and business.

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.

Job Description

Roles and Responsibilities

• Provides regulatory strategy and direction to the business for Software as a Medical Device (SaMD), including cloud-hosted software, connected solutions, and AI/ML-based technologies, across product development, product launch, premarket submissions/registrations, and post-market compliance activities, working closely with global regulatory authorities.
• Supports regulatory planning and execution for global submissions and registrations (e.g., FDA, EU MDR/IVDR) and jointly with regional experts (e.g. UKCA, Health Canada, PMDA, and other global markets), ensuring alignment with evolving digital health and software regulatory frameworks.
• Develops specialized depth and/or breadth of expertise in regulatory requirements applicable to SaMD, including software lifecycle processes, cybersecurity, AI/ML considerations, and post-market surveillance. Serves as a best-practice and quality resource within the function.
• Maintains awareness of emerging regulatory trends, guidance, and standards impacting digital health, cloud-based software, and AI technologies, and contributes to regulatory strategy and policy development within the assigned area of responsibility.
• Acts as a skilled influencer, communicating complex regulatory concepts related to software and digital technologies to cross-functional stakeholders. Serves as a resource for colleagues with less experience and may lead small to moderate regulatory projects with defined risk and resource requirements.
• Explains complex or sensitive regulatory topics clearly, works to build consensus across functions, and applies developing persuasion skills to influence decisions within the regulatory and product development space.
• Impacts approaches, projects, and programs within the regulatory function and supported business organizations, contributing to quality, efficiency, and effectiveness of regulatory deliverables.
• Operates with moderate autonomy within broad policies and guidelines, exercising sound evaluative judgment in regulatory decision-making related to software technologies.
• Uses regulatory and technical expertise to analyze data, assess regulatory risk, and support recommendations. Leverages multiple internal and limited external sources outside of own function to arrive at well-reasoned regulatory decisions.

Required Qualifications

• Bachelor’s Degree in Scientific, Engineering, Computer Science, or related discipline, or a minimum of 8 years of relevant work experience.
• A minimum of 4 years of Regulatory Affairs and/or Quality Assurance experience.
• A minimum of 4 years of experience in the medical device, digital health, or pharmaceutical industry.

Desired Characteristics

• Experience with Software as a Medical Device (SaMD), digital health, cloud-based medical software, and/or AI/ML-enabled medical technologies.
• Understanding of regulatory frameworks and standards applicable to software and digital health (e.g., FDA SaMD guidance, EU MDR software rules, IEC 62304, ISO 14971, cybersecurity).
• Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines.
• Regulatory Affairs Certification (RAC).
• Experience managing regulatory activities and projects within global regulatory environments and working effectively across different cultures and regions.
• Excellent verbal and written communication and presentation skills, with the ability to communicate clearly and convincingly in English and tailor messaging to diverse stakeholders.
• Demonstrated understanding of the healthcare and digital health environment, including awareness of competitive, commercial, and regulatory trends impacting software and AI-based medical technologies.
• Ability to document, plan, and execute regulatory programs and projects; established project management skills.
• Demonstrated ability to analyze and resolve problems, assess regulato