General Electric Regulatory Affairs Leader in Waukesha, Wisconsin
Job Description Summary
Provides 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.
Understanding of key business drivers; uses this understanding to accomplish own work. 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.
- This position can be remote from selected areas*
Roles and Responsibilities
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance.
Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
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.
Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
Review and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Contributes to writing and editing technical documents.
Bachelor's Degree or equivalent in a STEM field
3+ years experience in medical device regulatory affairs or quality.
Ability to work independently in fast-paced environment with little supervision.
Ability to adapt to constant change and influence positive change effectively.
Team-oriented and responsive to customer needs.
Ability to understand technical documentation and execute associated procedures
Experience in 510(k) submission and SaMD/AI is a plus
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.
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.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.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 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).
Relocation Assistance Provided: No