Senior Manager, Regulatory Affairs

GE HealthCare UK

Multiple Locations
Base: $132,000.00-$198,000.00 annual; bonus/equity...
On-site
Regulatory strategy for samd
Global regulatory submissions
Digital health regulatory frameworks
GE HealthCare UK is seeking a Senior Manager for Regulatory Affairs, focusing on the regulatory strategy for Software as a Medical Device (SaMD) and related technologies. The ideal candidate should have significant experience in regulatory affairs within the medical device or digital health industries

Job Summary

  • Provides regulatory strategy and direction for Software as a Medical Device (SaMD), including cloud-hosted software, connected solutions, and AI/ML-based technologies.
  • Supports regulatory planning and execution for global submissions and registrations, ensuring alignment with evolving digital health and software regulatory frameworks.
  • Acts as a skilled influencer, communicating complex regulatory concepts related to software and digital technologies to cross-functional stakeholders.

Matching Summary

Match Score: 85

GE HealthCare UK is seeking a Senior Manager for Regulatory Affairs, focusing on the regulatory strategy for Software as a Medical Device (SaMD) and related technologies. The ideal candidate should have significant experience in regulatory affairs within the medical device or digital health industries.

Salary

Base: $132,000.00-$198,000.00 Annual; Bonus/Equity: Performance based incentive compensation; Benefits: Medical, dental, vision, 401(k) plan, etc.

Skills & Requirements

Must-have

  • Regulatory strategy for SaMD
  • Global regulatory submissions
  • Digital health regulatory frameworks
  • Software lifecycle processes
  • Emerging regulatory trends

Nice-to-have

  • AI/ML regulatory considerations
  • Cybersecurity regulatory expertise
  • Cross-functional stakeholder communication
  • Influencing regulatory decisions

Key Requirements

  • Bachelor’s Degree or 8 years of relevant work experience
  • 4 years of Regulatory Affairs/Quality Assurance experience
  • 4 years in medical device, digital health, or pharmaceutical industry
  • Experience with SaMD, digital health, or AI/ML medical technologies
  • Understanding of regulatory frameworks for software and digital health
  • Regulatory Affairs Certification (RAC) desired

Work Rights

Not specified

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