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Job Description Summary
In this role you will create and manage global 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 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.
Job Description
Roles and Responsibilities
Develops and owns the comprehensive regulatory strategies for medical device products, focused on continuity of manufacturing operations
Anticipates and Identifies business risk and provide mitigation plans where applicable.
Takes initiative in identifying and resolving regulatory holds, submissions issues, regulatory queries and escalates to management accordingly.
Manage competing priorities in alignment with current business needs.
Evaluates revolving 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.
Independently drives regulatory requirements for product launch, authors premarket submissions/registrations, and performs change assessments in accordance with business timelines.
Proactively partners across the regulatory organization and cross functionally with Engineering, Clinical, Integrated Supply Chain, and Scientific, to support global submissions in key markets.
Reviews, recommends and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Builds and maintains working relationships with cross functional project teams and provides proactive clear communication on regulatory deliverables.
Required Qualifications
Bachelor's degree in a Scientific, Engineering, or a related degree.
A minimum of 4 years of experience in a regulated industry
A minimum of 3 years of experience in pharma or medical device Regulatory Affairs
Demonstrated project management skills
Willingness to work flexible hours when needed to accommodate needs of global customers and colleagues.
Demonstrated experience and proficiency with MS Office such as MS word, Excel, SharePoint, PowerPoint, etc.
Desired Characteristics
5+ years in regulated industry
Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs.
Experience with high risk, life supporting, and life-sustaining products and/or experience with 3rd party OEM registration projects.
Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly, 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.
Masters 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.
Demonstrates humility and can be assertive when needed.
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.
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Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf) . 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No