General Electric Regulatory Affairs Manager in Salt Lake City, Utah
Job Description Summary
This position will provide the expertise in Regulatory Affairs for the GE Healthcare Image Guided Therapies business organization. You will provide strategic regulatory directions to the business regarding regulatory requirements for product launch, submissions, and post market compliance. You will as an individual contributor expert to prepare regulatory strategies, premarket submissions, post market reporting, regulatory intelligence, regulatory requirements flow-down, post market compliance (e.g., advertising / promotion, etc.). May also provide program management to cross functional teams. This position is located on-site in Salt Lake City, Utah.
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.
Roles and Responsibilities
Creates and files submissions; communicates with authorities regarding these submissions.
Researches, analyzes, integrates, and organizes background information from diverse sources for regulatory submissions.
Program manages global submissions for assigned product line or new product introductions.
Ensures compliance with pre- and post-market product approval requirements.
Works closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility.
Provides strategic input on regulatory requirements to development teams.
Analyzes and communicates proposed, new, or changing requirements and devices strategies for their implementation, ensuring business goals are met.
Educates, trains, and advises company professionals to ensure compliance with RA requirements.
Collects, summarizes, and evaluates performance metrics to identify program weaknesses and drive improvements in procedures or oversight.
Supports continuous improvement activities about areas of responsibility.
Drives the development of regulatory strategy and update strategy based upon regulatory changes.
Provides RA oversight to clinical studies and ensure clinical data requirements for product licensing globally are documented in the compliance plan.
Supports regulatory inspections as required.
Participates in professional associations, industry/ trade groups and appropriate standards organizations.
Coaches or mentors other RA professionals.
Bachelor's Degree or a minimum of 7 years work experience.
5 years Regulatory Affairs / Quality Assurance experience.
A minimum of 5 years’ experience in the medical device industry.
Minimum of 1 year experience of regulatory project management and regulatory agency interactions.
Experience of management of regulatory projects in global regulatory organizations.
Experience of working globally and across different cultures.
Ability to communicate effectively in English (both written and verbal).
Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications.
Advanced degree in scientific, technology or regulatory affairs disciplines
Regulatory Affairs Certification (RAPS)
Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial, or political situations and their impact on GEHC regulatory strategies. Strong team leadership skills, facilitates teamwork
Assertive and willing to make decisions; uses multiple internal and limited external sources outside of own function to arrive at decisions
Skilled influencer, able to communicate complex messages to others with terms adapted to the audience
Acts as a resource for colleagues with less experience
Explains difficult or sensitive information; works to build consensus
Developing persuasion skills required to influence others on topics within field
Ability to juggle and prioritize multiple competing priorities and complete tasks on-time
Tenacious and delivery focused
Ability to make sound business judgments
Experience in LEAN management
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).
As a federal government contractor, GE requires U.S. employees to be fully vaccinated against COVID-19 unless you receive an approved medical or religious accommodation. Proof of vaccination will be required.
Relocation Assistance Provided: Yes