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GE HealthCare · 1 day ago

Head of Regulatory Affairs – US & Canada, PDx

United States

Full-time

Remote

Director/Executive

$180K/yr - $270K/yr

7+ years exp

GE HealthCare is a leading global medical technology and digital solutions innovator. They are seeking a Head of Regulatory Affairs to provide strategic regulatory leadership for their Pharmaceutical Diagnostics business across the US and Canada, driving regulatory strategy for product development and ensuring compliance with regulatory requirements.

AppsHealth CareHealth DiagnosticsHome ImprovementHome RenovationInternetMedical

Growth Opportunities

No H1B

U.S. Citizen Only

Responsibilities

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

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

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

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

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

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

Qualification

Regulatory AffairsFDA EngagementPharmaceutical IndustryLeadership ExperienceStrategic ThinkingProject ManagementAnalytical SkillsTeam DevelopmentCommunication SkillsNegotiation Skills

Required

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

Preferred

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

Benefits

Medical

Dental

Vision

Paid time off

A 401(k) plan with employee and company contribution opportunities

Life

Disability

Accident insurance

Tuition reimbursement

Company

GE HealthCare

Glassdoor4.2

GE Healthcare provides a wide range of medical technologies and services to healthcare providers and researchers. It is a sub-organization of General Electric.

Founded in 1892

Chicago, Illinois, USA

10001+ employees