Director Of Regulatory Affairs - Avs Digital

GEHC

Multiple Locations
Base: $153,600.00-$230,400.00 annual; bonus/equity...
Software lifecycle processes
Software as a medical device
Artificial intelligence/machine learning
This position provides strategic regulatory direction to the Digital subsegment of Advanced Visualization Solution (AVS) business regarding regulatory requirements for product launch, global submissions and post-market compliance

Job Summary

  • This position provides strategic regulatory direction to the Digital subsegment of Advanced Visualization Solution (AVS) business regarding regulatory requirements for product launch, global submissions and post-market compliance.
  • They lead a team of regulatory professionals in preparing regulatory strategies, premarket submissions, post-market reporting and responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and advertising / promotion, as applicable.
  • GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

Matching Summary

This position provides strategic regulatory direction to the Digital subsegment of Advanced Visualization Solution (AVS) business regarding regulatory requirements for product launch, global submissions and post-market compliance.

Salary

Base: $153,600.00-$230,400.00 Annual; Bonus/Equity: performance based incentive compensation; Benefits: medical, dental, vision, paid time off, a 401(k) plan, life, disability, and accident insurance, and tuition reimbursement

Skills & Requirements

Must-have

  • Software Lifecycle processes
  • Software as a Medical Device
  • Artificial Intelligence/Machine Learning
  • Cybersecurity
  • global submissions
  • post-market compliance

Nice-to-have

  • strategic partner to the business
  • skilled influencer
  • collaborative, inclusive, open and team based culture
  • proactive initiatives
  • emerging regulatory trends

Key Requirements

  • Bachelor's Degree in Scientific or Engineering
  • 10 years work experience
  • 7 years Regulatory Affairs / Quality Assurance
  • 7 years medical device or pharmaceutical industry
  • 2 years people management
  • 2 years project management
  • 2 years regulatory agency interactions

Work Rights

Legally authorized to work in the United States

Tailored Resume

Cover Letter