Shire Jobs

Job Description Summary

As the leader of a team of regulatory professionals, this position provides strategic regulatory leadership to the Consumables (Clinical Accessories) and Service businesses regarding regulatory requirements for product launch, market authorizations, and ongoing post market compliance requirements. You are an essential leader with the cross-functional business leadership teams for the business in operations, optimization, and strategic planning.

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

• Provides deep domain expertise in regulatory areas critical to the Consumables (Clinical Accessories) and Service businesses, preparing sustainable plans for got to market and to stay on market for a diverse array of monitoring, life supporting, and life sustaining devices, understanding requirements for biocompatibility, reprocessing, medical software, cybersecurity, and market requirements.

• Leads a team of regulatory professionals in execution of regulatory affairs tasks in support of the businesses.

• Prepares global regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering, Clinical, and Scientific, and submits premarket submissions to regulatory authorities such as FDA, NMPA, PMDA, MFDS, EU, etc., as per business’ timelines.

• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership.

• Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements.

• Integrates complex and diverse programs, executing sound project management techniques, and is effective in both formal and informal influencing across the organization.

• Seeks out and implements proactive initiatives to improve and enhance the regulatory compliance and efficiency for the team and opportunities to learn in new scientific or technical areas important to the business.

Required Qualifications

• Bachelor's Degree in a Scientific, Engineering, or other core Life Science discipline, or another complimentary discipline with a combination of training and experience demonstrating the equivalent.

• A minimum of 10 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics.

• A minimum of 5 years Regulatory Affairs / Quality Assurance experience.

• A minimum of 3 years experience managing other technical employees.

• A minimum of 3 years experience in regulatory project management/program management and regulatory agency interactions.

Desired Characteristics

• Experience preferred with high risk, life supporting, and life-sustaining products.

• Advanced degree in scientific, technology or regulatory affairs disciplines.

• Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GE Healthcare regulatory strategies.

• Experience working with global teams, preparing markets and customers for innovative products, and executive reporting skills using visual management, LEAN, or Kaizen.

• Strong team leadership skills, facilitates teamwork, proven ability to lead and inspire.

• Demonstrated life-long learner; eagerness to obtain new skills and knowledge.

• Humility in understanding, but assertive when needed; willing to make decisions and assign clear priorities.

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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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: Yes