Director of Regulatory Strategy, Science and Technology Organization
Remote
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.Job Description
Roles and Responsibilities:
Provides high quality regulatory advice and is seen as a valued strategic partner to the business you support.
Serve as Subject Matter Expert within a global team of regulatory professionals and execute on regulatory affairs tasks including global submissions and supporting product development in compliance with global regulations, in collaboration with cross-functional teams like engineering, data science.
Provides deep domain expertise in regulatory areas critical to the business including software as a medical device, health software, clinical decision support, AI enabled software, and cybersecurity.
Assesses changes in existing products and determines the need for new / revised licenses or registrations.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership.
Leads regulatory inspection support for sites, as well as support for regulatory inquiries from authorities related to adverse events or recalls.
Performs a broad variety of tasks in support of product and process design and support for regulatory and business leadership on operational and efficiency metrics.
Supports and encourages a collaborative, inclusive, open and team- based culture across his / her organization. Provides mentorship and career growth opportunities to the regulatory team.
Is an active member of external industry trade associations and/or standards organization …
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Benefits/PerksAccident Insurance Career growth opportunities Career opportunities Challenging careers Collaboration Collaborative culture Competitive benefits package Competitive compensation Dental Flexibility Global strength and scale Global team environment Great work environment Life, disability, and accident insurance Medical Medical, Dental, Vision Paid Time Off Professional development Support Tuition reimbursement Vision
Tasks- Collaboration
- Compliance
- Development
- Ensure compliance with regulations
- Serve as subject matter expert
- Support product development
Advertising AI Clinical Clinical decision support Clinical operations Collaboration Communication Compliance Cross-functional Collaboration Cybersecurity Data Digital solutions Engineering IT Leadership Mentorship Planning Presentation Process Product Development Program Management Project Management Quality Assurance Regulatory Affairs Regulatory Compliance Regulatory strategy Regulatory Submissions Reporting Software Software Applications Software as a medical device Strategic planning Team Collaboration Teams Technology
Experience10 years
EducationAS Bachelor's Bachelor's degree Business Engineering English Healthcare Project Management Science
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9