Advanced Specialist, Regulatory Product Strategy & Delivery (remote)

ResMed

Regulatory strategy for product lifecycle
Experience with software as a medical device
Authoring fda regulatory submissions
The primary role of Regulatory Affairs is to ensure compliance and optimal regulatory strategies for product development

Job Summary

  • The primary role of Regulatory Affairs is to ensure compliance and optimal regulatory strategies for product development.
  • This position supports software-driven health solutions and requires experience with digital health technologies.
  • Joining ResMed means being part of a culture that values diversity and innovation.

Matching Summary

The primary role of Regulatory Affairs is to ensure compliance and optimal regulatory strategies for product development.

Skills & Requirements

Must-have

  • Regulatory strategy for product lifecycle
  • Experience with Software as a Medical Device
  • Authoring FDA regulatory submissions

Nice-to-have

  • Experience with AI/ML-enabled medical devices
  • Familiarity with cybersecurity considerations
  • Working in agile development environments

Key Requirements

  • Bachelor’s degree
  • Minimum of 3 years in regulatory affairs
  • Experience with EU MDR requirements

Work Rights

Not specified

Tailored Resume

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