Job Description Summary

In this role you will provide strategic regulatory leadership to the Science and Technology Organization for the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (Medical device and non-Medical Device). You will join a global regulatory professional team focused on Digital Products and lead a team with a special focus on GenAI enabled products. You will establish strong partnership with the business team to identify and ensure compliance with regulatory requirements throughout the product lifecycle from development to product launch, to post-market activities of software products in scope. You will work on defining the regulatory strategies for products in development, premarket submissions, post-market reporting and responses to regulator inquiries, regulatory requirements flow-down and post-market compliance (e.g. advertising / promotion, etc.), as applicable. You will also support regulatory intelligence and influencing activities in Digital Health (e.g., AI, Clinical Decision Support, Cybersecurity).

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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:

• Provide deep domain expertise in regulatory areas critical to the business including software as a medical device, health software, clinical decision support, AI-enabled software (deep learning and generative AI), and cybersecurity.

• Provide high quality regulatory advice and is seen as a valued strategic partner to the business you support.

• Serve as subject matter expert within a global team of regulatory professionals and execute on regulatory affairs tasks including global submissions and supporting product development in compliance with global regulations, in collaboration with cross-functional teams like engineering, data science.  

• Research, analyze, integrate and organize background information from diverse sources for regulatory submissions and strategic planning with leadership.

• Assess changes in existing products and determines the need for new / revised licenses or registrations.

• Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

• Support and encourage a collaborative, inclusive, open and team- based culture across your organization. Provides mentorship and career growth opportunities to your reports.

• Represent GEHC in external industry trade associations, standards organization to help shape regulatory requirements in Digital Health.

• Implement proactive initiatives to streamline processes and best practices across the organization.

Required Qualifications:

• Bachelors Degree in a Scientific or Engineering discipline.

• A minimum of 7 years Regulatory Affairs / Quality Assurance experience in a medical device or pharmaceutical industry, regulator or notified body.

• Significant experience with software products, AI enabled medical devices.

• Strong experience with management of regulatory projects in global regulatory organizations and working globally and across different cultures.

• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.

Desired Characteristics:

• Prior experience with team management or leadership.

• Advanced degree in scientific, technology or regulatory affairs disciplines

• Experience with regulatory project management/program management and regulatory agency interactions.

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

• Ability to work in a matrix environment and engage relevant stakeholders.

• Strong leadership skills, team-player, proven ability to lead and inspire.

• Ability to make sound business judgments both with independence and knowing when to seek advice and support.

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.

For U.S. based positions only, the pay range for this position is $148,000.00-$222,000.00 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: March 21, 2025