Job Description Summary

As a Director you will provide strategic regulatory leadership to the Science and Technology Organization for the development and commercialization of AI-enabled, Cloud-deployed software applications used in clinical operation, as clinical information systems, and as clinical decision support. You will join a global regulatory professional team focused on Digital Products and work closely with business team to identifying and ensuring compliance with regulatory requirements for product launch, market authorization, and postmarket activities of product in scope. You will work on preparing regulatory strategies for product in development, premarket submissions, postmarket reporting and responses to regulator inquiries, regulatory requirements flow-down and postmarket compliance (e.g. advertising / promotion, etc.), as applicable. You will also support regulatory intelligence and influencing activities in Digital Health (e.g., AI, Clinical Decision Support, Cybersecurity).

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 and/or other relevant external groups to help shape regulatory requirements.

• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business.

Required Qualifications:

• Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years' work experience.

• A minimum of 8 years Regulatory Affairs / Quality Assurance experience.

• A minimum of 8 years' experience in the medical device or pharmaceutical industry.

• A minimum of 4 years’ experience of regulatory project management/program management and regulatory agency interactions.

• Experience preferred with software enabled products, AI containing medical device, or high-risk devices.

• Strong experience with management of regulatory projects in global regulatory organizations and working globally and across different cultures.

• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.

Desired Characteristics:

• Advanced degree in scientific, technology or regulatory affairs disciplines

• Regulatory Affairs Certification (RAPS).

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

• Strong leadership skills, team-player, proven ability to lead and inspire