Regulatory Affairs Leader - Ai Software Devices (f/m/d)

GE HealthCare UK

Not specified
Proven experience in regulated ai software field
Advanced practical experience in quality & regulatory affairs
Bachelor's degree in software engineering or regulatory affairs
GE HealthCare is seeking a Regulatory Affairs Leader to support its Women's Health Ultrasound business, focusing on AI software products. The role involves collaboration with global teams to ensure compliance with healthcare regulations and optimize submission strategies for product launches

Job Summary

  • This role provides regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs within GE HealthCare's Women's Health business.
  • The successful candidate will collaborate closely with the AI feature design team in Zipf and the global regulatory team to ensure premarket and postmarket compliance.
  • GE HealthCare offers a culture of care and collaboration where every voice makes a difference in building a healthier world.

Matching Summary

Match Score: 85

GE HealthCare is seeking a Regulatory Affairs Leader to support its Women's Health Ultrasound business, focusing on AI software products. The role involves collaboration with global teams to ensure compliance with healthcare regulations and optimize submission strategies for product launches.

Skills & Requirements

Must-have

  • Proven experience in regulated AI software field
  • Advanced practical experience in Quality & Regulatory Affairs
  • Bachelor's degree in software engineering or regulatory affairs

Nice-to-have

  • Strong project management skills
  • Excellent oral and written English communication
  • Ability to analyze and resolve complex problems

Key Requirements

  • Experience in regulated AI software domain
  • Degree in software engineering or regulatory affairs
  • Fluency in English (written and oral)

Work Rights

Not specified

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