Head of Regulatory Affairs – US & Canada, PDxJoin to apply for the Head of Regulatory Affairs – US & Canada, PDx role at GE HealthCare.This role reports to the Global Head of Regulatory Affairs for 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. Acts as the primary liaison with FDA, Health Canada, and other authorities, influencing outcomes and accelerating time‑to‑market.Key ResponsibilitiesRegulatory Strategy & ExecutionDevelop 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 EngagementLead interactions with FDA, Health Canada, and other regulatory bodies; manage negotiations andresponses to agency queries.Represent GE HealthCare PDx in regulatory meetings and industry forums.Cross‑Functional LeadershipCollaborate with R&D, Manufacturing, Quality, Clinical, and the Commercial team to integrate regulatory requirements into development plans and commercialization strategies.Support the RA team providing regulatory guidance on labeling, advertising, and promotional materials.Team LeadershipLead 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 & ComplianceEnsure adherence to FDA, Health Canada,



and ICH guidelines; maintain compliance andregistration dossiers.Drive initiatives to improve regulatory efficiency and proactively manage compliance risks.Business SupportParticipate in due diligence for product development, acquisitions, and in‑licensing opportunities; assess regulatoryrisksand requirements.Support budget planning for the Regulatory Affairs function.QualificationsBachelor’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 ofCMC, 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 CharacteristicsStrategic 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.Robust project management and organizational skills; ability to managecomplex 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. Compensation decisions are dependent on facts and circumstances. This position may also be eligible to earn performance‑based incentive compensation, including cash bonus(es) and/or long‑term incentives (LTI). 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.Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.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).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.Relocation Assistance Provided: NoApplication Deadline: February 09, 2026#J-18808-Ljbffr

📌 Head Of Regulatory Affairs – Us & Canada, Pdx - $180,000 - $270,000 A Year (Toronto)
🏢 GE Healthcare
📍 Toronto