Job Description Summary

This position provides strategic regulatory direction to the Digital subsegment of Advanced Visualization Solution (AVS) business regarding regulatory requirements for product launch, global submissions and post-market compliance. They lead a team of regulatory professionals in preparing regulatory strategies, premarket submissions, post-market reporting and responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and advertising / promotion, as applicable. Supports the cross-functional business leadership team in operations and strategic planning.

Job Description

Roles and Responsibilities

• Provides high quality regulatory advice and is seen as a valued strategic partner to the business they supports
• Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the business
• Provides deep domain expertise in regulatory areas critical to the Digital subsegment of the AVS business including Software Lifecycle processes, Software in or as a Medical Device, Artificial Intelligence/Machine Learning, Cybersecurity
• 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
• Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering/R&D/Clinical and submits premarket submissions to regulatory authorities, as per business timelines
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
• Supports and encourages a collaborative, inclusive, open and team based culture across their organization and the larger Regulatory Affairs organization and in particular the Digital Regulatory Affairs team
• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business.

Required Qualifications

• Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience
• A minimum of 7 years Regulatory Affairs / Quality Assurance experience
• A minimum of 7 years' experience in the medical device or pharmaceutical industry 
• A minimum of 2 years experience of people management, project management, and regulatory agency interactions ​

Desired Characteristics

• Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines.
• 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).
• 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 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
• Ability to make sound business and regulatory judgments independently, while recognizing when to seek guidance and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $153,600.00-$230,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Application Deadline: April 14, 2026