Regulatory Affairs Leader

Job Description Summary

As a Regulatory Affairs Leader, you will be supporting GE Health Care'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.

• 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, integrate and organize background information from diverse sources for regulatory submissions
• Apply regulatory requirements and understand their impacts on submissions and pre- and post-market compliance.

• Proven experience working in a regulated field, especially AI software ; advanced practical experience in the Quality & Regulatory Affairs
• Bachelor's degree in software engineering, regulatory affairs or equivalent
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Strong communication skills in .

Relocation Assistance Provided:
No

GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.