Job Description Summary

In this role you will create and manage global regulatory submissions for Patient Care Solutions products focused on continuity of global manufacturing operations. This will include providing strategic regulatory requirements for product deployment, maintenance, premarket submissions/registrations, and post market compliance.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission 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.

Job Description

Roles and Responsibilities

• Develops comprehensive regulatory strategies for medical device products, focused on continuity of manufacturing operations and under minimal supervision.
• Navigates evolving global regulatory requirements to facilitate and maintain market access. Assesses changes in existing products to determine the need for new / revised global licenses or registrations.
• Identifies regulatory requirements for product launch, authors premarket submissions/registrations, and performs change assessments in accordance with business timelines.
• Collaborates across the regulatory organization and cross functionally with Engineering, Clinical, Integrated Supply Chain, and Scientific, to support global submissions in key markets.
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
• Builds and maintain working relationships with cross functional project teams and provide clear communication on regulatory deliverables.
• Takes initiative in identifying and resolving regulatory holds, submissions issues, regulatory queries and escalates to management accordingly.

 Required Qualifications

• Bachelor's degree in a Scientific, Engineering, Computer Sci