Job Description
Job Description Summary As a Regulatory Affairs Leader, you will be supporting GE HealthCare 's Women's Health Ultrasound business. You will be collaborating closely with the AI feature design team in our Zipf site, as well as with the global regulatory team. You will be responsible for providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. 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 Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership. Support compliance of premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally. Develop regulatory strategies to help optimize regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions. Utilise technical expertise and judgement to solve problems. Assesse changes in existing products and determine the need for new / revised licenses or registrations. Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements. Contribute to writing and editing technical documents Researche, analyze,
