Lead Specialist, Regulatory Affairs

GE HealthcareHealthcare Quality & Regulatory

Category

QualityMid-Career

Job Id

R Relocation Assistance No

Job Description Summary

In this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories& Supplies (A&S) products. Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier contract for initial global market access, maintenance of global registrations, and continuous upkeep as business needs arise.

Job Description

Roles and Responsibilities

• Collaborates across the regulatory organization and cross-functionally with product managers to support global submission documentation requirements in identified markets.
• Requests and maintains supplier documentation in designated document databases specific to global product registration approvals.
• Builds and maintain working relationships with third party suppliers to ensure qualifying supplier documentation is obtained and maintained such as credentialing documents, international certificates, product labels, letters of authorization, and other requirements for global submissions that support supplier country scope of distribution.
• Under the instruction of A&S Product RA, maintain regulatory strategies for medical device products, focused on continuity of supplier operations and under minimal supervision.
• Gather and update global regulatory requirements to facilitate and maintain market access in global markets. Assesses changes in existing products to determine the need for new / revised global licenses or registrations.
• Ensure regulatory requirements from existing third-party suppliers performs, updates and provides country license information in accordance with business timelines.

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 8+ years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals or biologics.
• A minimum of 6+ year's experience in international Regulatory Affairs or supplier quality 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, supply quality engineering, 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.

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 – 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'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

Additional Information

Relocation Assistance Provided: No