Head of Regulatory Affairs – US & Canada, PDx

GE HealthCare

2d

About The Position

This role reports to the Global Head of Regulatory Affairs GE HealthCare’s Pharmaceutical Diagnostics (PDx). This role provides strategic regulatory leadership for GE HealthCare’s Pharmaceutical Diagnostics (PDx) business across the US and Canada. This role drives 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, 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 every difference builds a healthier world.

Requirements

• 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.

Nice To Haves

• Background in sterile injectables; radiopharmaceutical experience is a strong asset.
• 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.

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 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 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.

Benefits

• 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.
• 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.
• GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees