GE HealthCare Lead Specialist Regulatory Affairs Transfers 

United States, Wisconsin 

400727724

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.

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 Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent.
• A minimum of 3 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, biologics, logistics operations related to import/export compliance.
• A minimum of 1 years’ experience in Regulatory Affairs and operations supporting global compliance.
• Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.
• Adept at utilizing research tools and capable of synthesizing complex information to support submissions and decision-making processes.
• Strong project management, communication, and interpersonal skills.
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, Adobe Acrobat, project management and collaboration applications.

Desired Characteristics

• Experience with supporting manufacturing operations, maintaining continuity of such operations, and strategic experience in optimizing how products are registered globally.
• Experience with high risk, life supporting, and life-sustaining products preferred.
• Advanced degree in scientific, technology or regulatory affairs disciplines.
• Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
• Learning oriented and eager to obtain new skills and knowledge. Demonstrates flexibility in understanding new and evolving regulations.
• Humility in understanding, but assertive when needed.

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.