Program Manager, Regulatory Affairs

GE HealthCare is seeking a Regulatory Affairs Program Manager to lead global regulatory strategies for medical imaging products, including Mammography imaging and new AI applications. This role drives cross-functional collaboration to bring innovative products to market and supports patient care and healthcare outcomes worldwide. Responsibilities Lead global regulatory projects to secure market authorization and promotional approval for medical devices. Collaborate with product development teams (engineering, marketing, clinical investigations, regional regulatory experts). Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines. Identify and define product testing and clinical study requirements to support regulatory submissions. Analyze and organize scientific data to demonstrate safety and efficacy of medical devices. Prepare and submit regulatory documentation to authorities across global markets (US, Canada, Latin America, Europe, China, Asia). Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards. Evaluate design changes and determine licensing or registration needs. Review and approve promotional materials to ensure alignment with regulatory claims. Monitor regulatory trends and communicate new requirements to internal teams. Support regulatory inspections and audits as needed. Qualifications Advanced experience in Regulatory Affairs, ideally within the medical device industry, or advanced experience in product development within the medical device industry. Bachelor’s degree from an accredited university or college, or equivalent relevant experience. Strong analytical, problem-solving, and project management skills. Excellent oral and written communication abilities. Proficiency in English (written and spoken). Desired Characteristics Experience interacting with global regulatory agencies (e.g., FDA, Notified Bodies, NMPA). Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks. Ability to work independently in a fast-paced, dynamic environment. Adaptability to change and capability to drive positive transformation. Strong team orientation and responsiveness to customer needs. Detail-oriented with a focus on delivering results. Experience working in multicultural and cross-functional teams. About Us 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. Inclusion & 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. 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. Additional Information Relocation Assistance Provided: No Seniority level Mid-Senior level Employment type Full-time Job function Project Management and Information Technology Industries Hospitals and Health Care #J-18808-Ljbffr