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<h1>Job Description Summary</h1>Provides 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. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area. GE HealthCare is a leading global medical technology and digital solutions innovator

Our purpose is to create a world where healthcare has no limits. 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.<h1>Job Description</h1>Job Description: Lead Regulatory Affairs Specialist, JapanPosition Overview: Lead Specialist, Regulatory Affairs is responsible for all RA tasks of own modality with supervision by the direct manager or project leader. Report to direct manager or to project leader or to core-team co-workers about submission projects status when it’s requested

This role involves working closely with healthcare regulatory bodies and industry association and requires an in-depth understanding of key business drivers to accomplish work effectively.Key Responsibilities:<ul><li>Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets.</li><li>Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory, product claims and country regulatory dependencies to ensure optimized sequencing for submissions.</li><li>Works with a

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Lead Regulatory Affairs Specialist, Japan

About this role

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