Head of Regulatory Affairs – US

Job Description Summary This role reports to the Global Head of Regulatory Affairs at GE HealthCare’s Pharmaceutical Diagnostics (PDx). It provides strategic regulatory leadership for GE HealthCare’s PDx business across the US and Canada, driving regulatory strategy for product development, submissions, approvals, and post‑market compliance. The role acts as the primary liaison with FDA, Health Canada and other authorities, influencing outcomes and accelerating time‑to‑market. 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 builds a healthier world. Key Responsibilities Regulatory Strategy & Execution Develop and implement regional regulatory strategies to enable timely product approvals and lifecycle management. Interpret regulatory trends and business challenges to recommend best practices that enhance compliance and accelerate product development. Agency Engagement Lead interactions with FDA, Health Canada and other regulatory bodies; manage negotiations and responses to agency queries. Represent GE HealthCare PDx in regulatory meetings and industry forums. Cross‑Functional Leadership Collaborate with R&D, Manufacturing, Quality, Clinical, and Commercial teams to integrate regulatory requirements into development plans and commercialization strategies. Support the RA team by providing regulatory guidance on labeling, advertising, and promotional materials. Team Leadership Lead and mentor a team of regulatory professionals; set priorities, allocate resources, and ensure timely, high‑quality deliverables. Foster a culture of compliance, agility, and continuous improvement. Governance & Compliance Ensure adherence to FDA, Health Canada and ICH guidelines; maintain compliance and registration dossiers. Drive initiatives to improve regulatory efficiency and proactively manage compliance risks. Business Support Participate in due diligence for product development, acquisitions, and in‑licensing opportunities; assess regulatory risks and requirements. Support budget planning for the Regulatory Affairs function. Qualifications Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree preferred. 7+ years of regulatory affairs experience in the pharmaceutical industry, with proven leadership in US and Canadian markets. Expertise in regulatory pathways from IND through approval, launch and lifecycle management; strong understanding of CMC, Quality, non‑clinical and clinical components. Experience leading meetings with FDA and Health Canada. Background in sterile injectables; radiopharmaceutical experience is a strong asset. Desired Characteristics Strategic thinker with strong analytical and problem‑solving skills. Excellent oral and written communication; ability to influence and negotiate effectively. Proven leadership and team development capabilities. Strong project management and organizational skills; ability to manage complex priorities. We expect all employees to live and breathe our behaviors: 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. Salary ranges at $180,000–$270,000 for U.S. based positions, with eligibility for performance‑based incentives. Benefits include medical, dental, vision, paid time off, 401(k) with company match, life, disability, accident insurance and tuition reimbursement. Equal Employment Opportunity GE HealthCare is an Equal Opportunity Employer. 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. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. #J-18808-Ljbffr