Director of Regulatory Affairs - AVS Digital

GE HEALTHCARE

About The Position

This position provides strategic regulatory direction to the Digital subsegment of Advanced Visualization Solution (AVS) business regarding regulatory requirements for product launch, global submissions and post-market compliance. They lead a team of regulatory professionals in preparing regulatory strategies, premarket submissions, post-market reporting and responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and advertising / promotion, as applicable. Supports the cross-functional business leadership team in operations and strategic planning.

Requirements

Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience
A minimum of 7 years Regulatory Affairs / Quality Assurance experience
A minimum of 7 years' experience in the medical device or pharmaceutical industry
A minimum of 2 years experience of people management, project management, and regulatory agency interactions

Nice To Haves

Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines.
Experience with Software as a Medical Device (SaMD), digital health, cloud-based medical software, and/or AI/ML-enabled medical technologies.
Understanding of regulatory frameworks and standards applicable to software and digital health (e.g., FDA SaMD guidance, EU MDR software rules, IEC 62304, ISO 14971, cybersecurity).
Experience managing regulatory activities and projects within global regulatory environments and working effectively across different cultures and regions.
Excellent verbal and written communication and presentation skills, with the ability to communicate clearly and convincingly in English and tailor messaging to diverse stakeholders.
Demonstrated ability to analyze and resolve problems, assess regulatory risk, and support regulatory decision-making
Strong collaboration and leadership skills, with the ability to facilitate teamwork and influence
Ability to make sound business and regulatory judgments independently, while recognizing when to seek guidance and support.

Responsibilities

Provides high quality regulatory advice and is seen as a valued strategic partner to the business they supports
Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the business
Provides deep domain expertise in regulatory areas critical to the Digital subsegment of the AVS business including Software Lifecycle processes, Software in or as a Medical Device, Artificial Intelligence/Machine Learning, Cybersecurity
Maintains awareness of emerging regulatory trends, guidance, and standards impacting digital health, cloud-based software, and AI technologies, and contributes to regulatory strategy and policy development within the assigned area of responsibility
Acts as a skilled influencer, communicating complex regulatory concepts related to software and digital technologies to cross-functional stakeholders
Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering/R&D/Clinical and submits premarket submissions to regulatory authorities, as per business timelines
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements
Supports and encourages a collaborative, inclusive, open and team based culture across their organization and the larger Regulatory Affairs organization and in particular the Digital Regulatory Affairs team
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.