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

GE HealthCare UK

Zipf, Austria
On-site
Regulatory strategy and direction
Ai software regulatory requirements
Product launch and compliance
GE HealthCare is seeking a Regulatory Affairs Leader for their Women's Health Ultrasound business in Zipf, Austria. The role involves providing regulatory strategy and support for AI software devices, collaborating with global teams, and ensuring compliance with healthcare regulations

Job Summary

  • You will be responsible for providing 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.
  • Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership.
  • 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.

Matching Summary

Match Score: 85

GE HealthCare is seeking a Regulatory Affairs Leader for their Women's Health Ultrasound business in Zipf, Austria. The role involves providing regulatory strategy and support for AI software devices, collaborating with global teams, and ensuring compliance with healthcare regulations.

Skills & Requirements

Must-have

  • Regulatory strategy and direction
  • AI software regulatory requirements
  • Product launch and compliance
  • Global regulatory bodies collaboration
  • Premarket submissions and registrations
  • Postmarket compliance

Nice-to-have

  • Cross-functional team communication
  • Optimize regulatory submission pathways
  • Technical expertise and judgment
  • Advertising and promotion review

Key Requirements

  • Proven experience in a regulated field, especially AI software
  • Advanced practical experience in Quality & Regulatory Affairs
  • Bachelor's degree in software engineering, regulatory affairs or equivalent
  • Strong oral and written communication skills
  • Demonstrated ability to analyze and resolve problems
  • Established project management skills
  • Strong communication skills in English (both written and oral)

Work Rights

Not specified

Tailored Resume

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