Regulatory Affairs Leader - ARC

Job Description Summary

This position provides strategic regulatory leadership for major regulatory projects, programs and regulatory submissions, working closely with a cross-functional team and global regulatory bodies. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in compliance with regulatory requirements. The Regulatory Affairs Leader will be involved with regulatory activities in the areas such as premarket submissions, project management, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. 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

Responsibilities :

1. Provides regulatory leadership and strategic direction for ARC regulatory programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership. Supports compliance of premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.

2. Develops regulatory strategies to help optimize regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.

3. Explains information clearly with the right level of detail for the audience, and works to understand a situation, potential risks, and develop possible solutions; brings team members to consensus around topics within the field.

4. Recognizes when additional support from senior levels within RA is needed to ensure sound decisions are made and risks are minimized.

5. Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

6. Assesses changes in existing products and determines the need for new / revised licenses or registrations.

7. Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

8. Contributes to writing and editing technical documents

9. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions

10. Understands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance.

Qualifications :

1. This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college. 2. Minimum of 3 years experience working in a regulated field 3. Strong communication skills in English (both written and oral).

Characteristics :

1. Strong communication, project management, and organizational skills 2. Ability to work independently in fast-paced environment and adapt to change. 3. Has ability to prioritize information for data analysis and recognize when additional information and support is needed. 4. Team-oriented and responsive to customer needs. 5. Attention to Detail and Results-Oriented. 6. Ability to understand technical documentation and execute associated procedures

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

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. 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