Program Manager, Regulatory Affairs, Maternal Infant Care

About this role

<h1><b>Job Description Summary</b></h1>Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market<br><br>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.<p style="text-align:inherit"><br /> </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h1><b>Job Description</b></h1><p><b><span>Roles and Responsibilities</span></b></p><ul><li><p>Provides regulatory strategy and direction for the MIC business regarding healthcare industry regulatory requirements for product launch, premarket <span>submissions/registrations</span> and post-market compliance, working closely with healthcare regulatory bodies globally.</p></li><li><p>Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, EU, NMPA, PMDA, MFDS, CDSCO, etc., as per business’ timelines.</p></li><li><p>Assesses changes in existing products and determines the need for new / revised licenses or registrations.</p></li><li><p>Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.</p></li><li><p>Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help s

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