Head of Regulatory Affairs – US

Head of Regulatory Affairs – US & Canada, PDx This role reports to the Global Head of Regulatory Affairs GE HealthCare’s Pharmaceutical Diagnostics (PDx). It provides strategic regulatory leadership across the US and Canada, driving regulatory strategy for product development, submissions, approvals, and post‑market compliance, ensuring alignment with business objectives and regulatory requirements. Acts as the primary liaison with FDA, Health Canada, and other authorities. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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 and commercialization strategies. Support the RA team in 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: 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. 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 \$180,000.00–\$270,000.00 Annual. This position may also be eligible to earn performance‑based incentive compensation. GE HealthCare offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. 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. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). #J-18808-Ljbffr