Job Overview As a Regulatory Affairs Leader, you will be supporting GE HealthCare's Women's Health Ultrasound business. You will collaborate closely with the AI feature design team in our Zipf site and with the global regulatory team. Your responsibilities include providing regulatory strategy, direction, and support for product launch, pre‑market submissions, registration, and post‑market compliance, working with regulatory bodies worldwide.
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 senior leadership.
Support compliance of pre‑market submissions/registrations and post‑market compliance, working closely with regulatory bodies globally.
Develop regulatory strategies to optimize submission pathways, considering product testing, clinical data, product claims, and country regulatory dependencies to ensure optimal sequencing of submissions.
Utilize technical expertise and judgement to solve problems.
Assess changes in existing products and determine the need for new or 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.
Research, 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.
Required Qualifications
Proven experience working in a regulated field, especially AI software; advanced practical experience in 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 English (both written and oral).
Equal Opportunity Statement 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.
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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 senior leadership.
Support compliance of pre‑market submissions/registrations and post‑market compliance, working closely with regulatory bodies globally.
Develop regulatory strategies to optimize submission pathways, considering product testing, clinical data, product claims, and country regulatory dependencies to ensure optimal sequencing of submissions.
Utilize technical expertise and judgement to solve problems.
Assess changes in existing products and determine the need for new or 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.
Research, 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.
Required Qualifications
Proven experience working in a regulated field, especially AI software; advanced practical experience in 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 English (both written and oral).
Equal Opportunity Statement 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.
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