Regulatory Affairs Leader – AI Software Devices

🔥 8 minutes ago

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs • Support compliance of premarket submissions/registrations and post market compliance • Develop regulatory strategies to help optimize regulatory submission pathways • Utilize technical expertise and judgement to solve problems • Assess 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 • 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.

🎯 Requirements

• 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).

🏖️ Benefits

• Inclusion and diversity • Equal Opportunity Employer