Job Description

Summary

As a Manager within the Regulatory Submissions Management team, you will be responsible for providing regulatory submission publishing services in an efficient and timely manner. This role is the first point of contact for all customers of the Regulatory Operations group; and upholds \xe2\x80\x9cright first time\xe2\x80\x9d submission quality and timeliness. Your expertise on Regulatory Submission standards and requirements will perform a pivotal role in achieving GE Healthcare\xe2\x80\x99s strategies and responding to changing agency requirements.

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.

Responsibilities

In this role you will

• Use Veeva for Registrations to plan and track upcoming submissions and effectively manage workload
• Liaise with Regulatory Affairs and local affiliates to provide them with Submissions Management and hands-on Submissions Publishing support
• Work closely with Regulatory Submissions Management counterparts in other regions to facilitate global work sharing
• Advise customers on best practices within Submission publishing, Document Management (using Veeva Vault) and submission-ready document standards
• Train junior staff on submissions publishing and document standards
• Active participation in projects related to improving the publishing tools, standards, and processes
• Monitor agency guidance & changing regulations

Qualifications and Experience

• 5+ years of Submission Publishing and Submission Management principles is essential, with knowledge of formats, standards, and processes in major regions (Europe, United States, and Rest of the World)
• Hands-on experience with Submission Publishing, Validation and PDF manipulation software as well as Document Management and RIM systems (e.g., Veeva Vault)
• Ability to work effectively without direct supervision
• Willing to travel when required.

Desirable Skills

• Strong interpersonal skills and ability to engage effectively with colleagues at all levels
• Ability to resolve day-to-day issues, escalating issues that impact strategic initiatives
• Excellent IT skills, with the ability to learn new tools and systems quickly
• Experience working with outsource partners an advantage

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 \xe2\x80\x93 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\xe2\x80\x99d expect from an organization with global strength and scale, and you\xe2\x80\x99ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-Hybrid #LI-GM2

Additional Information

Relocation Assistance Provided: No