Key Responsibilities
Global Labeling Strategy
Lead global labeling strategy for assigned products, with primary focus on US FDA requirements and labeling expectations.
Provide labeling input to development programs, lifecycle management activities, and regulatory submissions.
Ensure alignment between US labeling, CCDS, and regional implementation strategies.
FDA Labeling Leadership
Lead preparation and review of US labeling content, including USPI and FDA labeling updates.
Support FDA interactions and labeling negotiations.
Assess regulatory risks and communicate the impact of FDA feedback on development and commercialization plans.
Cross-Functional Collaboration
Partner with Clinical, CMC, Safety, Medical, Market Access, Commercial, Legal, and Ad Promo teams to develop clear and defensible labeling positions.
Translate complex regulatory requirements into business-relevant recommendations.
Governance & Compliance
Support labeling governance processes and ensure inspection-ready documentation.
Drive timely implementation of labeling changes and continuous process improvement.
Contribute to labeling metrics, systems, and best practices across the organization.
CCDS Alignment & Global Implementation
Support CCDS creation, maintenance, version control, and change-control activities, ensuring US labeling decisions are assessed for global impact and properly reflected in global labeling governance.
Coordinate with global regulatory leads and regional RA teams to evaluate local implementation requirements, document deviations or exceptions from CCDS, and maintain transparent rationale for regional differences.
Track implementation of labeling changes across US and global markets, including milestones, dependencies, approvals, exceptions, and closure status.
Maintain labeling trackers, action logs, decision records, and implementation status to support global visibility and inspection readiness.
Required Qualifications
7+ years of Regulatory Affairs experience, including significant experience in labeling.
Strong knowledge of FDA labeling requirements and experience supporting US regulatory submissions.
Experience developing and maintaining US labeling and/or CCDS.
Ability to influence cross-functional teams and manage complex projects.
Excellent written and verbal communication skills.
Preferred Qualifications
Experience interacting with FDA on labeling matters.
Knowledge of EU and global labeling requirements.
Experience with Veeva RIM or similar regulatory systems.
Degree in Life Sciences, Pharmacy, or related field.
GE 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: No
Skills Required
- 7+ years of Regulatory Affairs experience, including significant experience in labeling.
- Strong knowledge of FDA labeling requirements and experience supporting US regulatory submissions.
- Experience developing and maintaining US labeling and/or Core Company Data Sheet (CCDS).
- Ability to influence cross-functional teams and manage complex projects.
- Excellent written and verbal communication skills.
- Experience interacting with FDA on labeling matters.
- Knowledge of EU and global labeling requirements.
- Experience with Veeva RIM or similar regulatory systems.
- Degree in Life Sciences, Pharmacy, or related field.
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
GE Healthcare Insights
What We Do
Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
