Regulatory Affairs Leader

🔥 14 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

🏥 Healthcare

💊 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

• Provides regulatory leadership and strategic direction for ARC regulatory programs • Supports global registration planning, submissions, notified body and quality system audits, and program implementation across cross-functional teams • Communicates with leadership and works with healthcare regulatory bodies globally • Develops regulatory strategies to optimize submission pathways, considering testing, clinical data, product claims, and country dependencies • Explains information clearly, assesses risks, develops solutions, and builds consensus • Recognizes when senior Regulatory Affairs support is needed • Uses technical expertise, judgment, and analytical thinking to solve problems • Assesses product changes and determines the need for new or revised licenses or registrations • Reviews and approves advertising and promotional materials for claims and regulatory compliance • Contributes to writing and editing technical documents • Researches, analyzes, integrates, and organizes information for regulatory submissions • Applies regulatory requirements to pre-market and post-market compliance

🎯 Requirements

• Advanced experience in Quality & Regulatory Affairs; knowledge level comparable to a Bachelor's degree from an accredited university or college • Minimum of 3 years of experience working in a regulated field • Strong communication skills in English, both written and oral • Strong communication, project management, and organizational skills • Ability to work independently in a fast-paced environment and adapt to change • Ability to prioritize information for data analysis and recognize when additional information and support is needed • Team-oriented and responsive to customer needs • Attention to detail and results-oriented • Ability to understand technical documentation and execute associated procedures • Legally authorized to work in the United States • Successful completion of a drug screen, as applicable

🏖️ Benefits

• Professional development opportunities • Challenging careers • Competitive compensation • Great work environment • Career opportunities • Culture that fosters care, collaboration and support

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