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

GE HealthCare Technologies

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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 for its Women's Health Ultrasound business, focusing on AI software devices. The role involves providing regulatory strategy and direction, ensuring compliance with healthcare regulations, and collaborating closely with the AI design and global regulatory teams. **

Job Summary

  • You will provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs across a global team.
  • The role involves developing strategies to optimize submission pathways while ensuring compliance with premarket and post-market requirements.
  • GE HealthCare offers a culture of care and collaboration where every voice makes a difference in building a healthier world.

Matching Summary

Match Score: 75

** GE HealthCare is seeking a Regulatory Affairs Leader for its Women's Health Ultrasound business, focusing on AI software devices. The role involves providing regulatory strategy and direction, ensuring compliance with healthcare regulations, and collaborating closely with the AI design and global regulatory teams. **

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
  • Strong oral and written communication skills in English
  • Ability to analyze and resolve complex regulatory problems

Nice-to-have

  • Experience with global healthcare regulatory bodies
  • Project management skills for cross-functional teams
  • Technical expertise in product testing and clinical data
  • Collaboration with AI feature design teams

Key Requirements

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

Work Rights

Not specified

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