Senior Manager, Regulatory Affairs

GE HealthCare

About The Position

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Requirements

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.

Nice To Haves

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 regulatory risk, and support regulatory decision-making.
Strong collaboration and leadership skills, with the ability to facilitate teamwork and influence without direct authority.
Ability to make sound business and regulatory judgments independently, while recognizing when to seek guidance and support.

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.