Regulatory Affairs Leader
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Job Description
Regulatory Affairs Leader guiding GE HealthCare’s medical technology compliance, submissions, and regulatory strategy. Leading cross-functional programs across global regulatory bodies and product lifecycle requirements.
Responsibilities:
- Provides regulatory leadership and strategic direction for ARC regulatory programs
- Supports global registration planning, submissions, notified body and quality system audits, and program implementation across cross-functional teams
- Communicates with leadership and works with healthcare regulatory bodies globally
- Develops regulatory strategies to optimize submission pathways, considering testing, clinical data, product claims, and country dependencies
- Explains information clearly, assesses risks, develops solutions, and builds consensus
- Recognizes when senior Regulatory Affairs support is needed
- Uses technical expertise, judgment, and analytical thinking to solve problems
- Assesses product changes and determines the need for new or revised licenses or registrations
- Reviews and approves advertising and promotional materials for claims and regulatory compliance
- Contributes to writing and editing technical documents
- Researches, analyzes, integrates, and organizes information for regulatory submissions
- Applies regulatory requirements to pre-market and post-market compliance
Requirements:
- Advanced experience in Quality & Regulatory Affairs; knowledge level comparable to a Bachelor's degree from an accredited university or college
- Minimum of 3 years of experience working in a regulated field
- Strong communication skills in English, both written and oral
- Strong communication, project management, and organizational skills
- Ability to work independently in a fast-paced environment and adapt to change
- Ability to prioritize information for data analysis and recognize when additional information and support is needed
- Team-oriented and responsive to customer needs
- Attention to detail and results-oriented
- Ability to understand technical documentation and execute associated procedures
- Legally authorized to work in the United States
- Successful completion of a drug screen, as applicable
Benefits:
- Professional development opportunities
- Challenging careers
- Competitive compensation
- Great work environment
- Career opportunities
- Culture that fosters care, collaboration and support
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