Lead Specialist, Regulatory Affairs

Summary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide 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 Key Responsibilities Lead global regulatory projects to secure market authorization and promotional approval for medical devices Collaborate closely with product development teams including engineering marketing clinical investigations and regional regulatory experts Develop and implement regulatory strategies aligned with business objectives including target markets clinical claims and timelines Identify and define product testing and clinical study requirements to support regulatory submissions Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices Prepare and submit regulatory documentation to authorities across global markets including the US Canada Latin America Europe China and Asia Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards Evaluate design changes and determine licensing or registration needs Review and approve promotional materials to ensure alignment with regulatory claims Monitor regulatory trends and communicate new requirements to internal teams Support regulatory inspections and audits as needed Required Qualifications Advanced experience in Regulatory Affairs ideally within the medical device industry or advanced experience in product development within the medical device industry Bachelor s degree from an accredited university or college or equivalent relevant experience Strong analytical problem-solving and project management skills Excellent oral and written communication abilities Proficiency in English written and spoken Preferred Qualifications Experience interacting with global regulatory agencies e g FDA Notified Bodies NMPA Knowledge of Quality Management Systems QMS and regulatory compliance frameworks Proven ability to work independently in a fast-paced dynamic environment Adaptability to change and capability to drive positive transformation Excellent team orientation and responsiveness to customer needs Detail-oriented with a focus on delivering results Experience working in multicultural and cross-functional teams Inclusion and Diversity 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 We expect all employees to live and breathe our behaviors to act with humility and build trust lead with transparency deliver with focus and drive ownership - always with unyielding integrity 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 LI-RS1 Hybrid Additional Information Relocation Assistance Provided No