Regulatory Affairs Leader - AI Software Devices (f/m/d)

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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, 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 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 English (both written and oral). 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. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support. -------------------------------------------------------------------------------------------------------------------------------- En tant que Responsable des Affaires Réglementaires, vous soutiendrez l'activité d'échographie dédiée à la santé des femmes chez GE HealthCare. Vous collaborerez étroitement avec l'équipe de conception des fonctionnalités d'IA sur notre site de Zipf, ainsi qu'avec l'équipe réglementaire mondiale. Vous serez responsable de fournir à l'entreprise la stratégie et les orientations réglementaires concernant les exigences du secteur de la santé pour les lancements de produits, les soumissions/enregistrements pré‑commercialisation et la conformité post‑commercialisation, en travaillant en étroite collaboration avec les autorités réglementaires de santé à travers le monde. GE HealthCare est un leader mondial des technologies médicales et des solutions numériques innovantes. Notre mission est d'améliorer la vie dans les moments qui comptent. Libérez votre ambition, transformez vos idées en réalités qui changent le monde et rejoignez une organisation où chaque voix compte et où chaque différence contribue à bâtir un monde plus sain. Rôles et responsabilités Assurer le leadership réglementaire et l'orientation stratégique pour les programmes logiciels d'IA en échographie, incluant le support réglementaire global pour la planification des enregistrements, les soumissions, les audits des organismes notifiés et du système qualité, ainsi que la mise en œuvre des programmes au sein d'une équipe interfonctionnelle, avec communication vers la direction. Soutenir la conformit

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