Advanced Specialist, Regulatory Product Strategy & Delivery (remote)

RESMED PTY

Fully remote
Software as a medical device experience
Fda 510(k) submission authoring
Eu mdr regulatory requirements knowledge
ResMed Pty is seeking an Advanced Specialist in Regulatory Product Strategy & Delivery to support their regulatory affairs function, particularly for software-driven and digital health solutions. The ideal candidate should have significant experience in regulatory affairs within the medical device sector, especially around Software as a Medical Device (SaMD) and relevant regulatory submissions

Job Summary

  • This role provides strategic regulatory guidance to ensure ResMed's products comply with global frameworks while supporting the design and development of safe medical devices.
  • The specialist acts as a key partner in cross-functional teams to translate complex regulatory requirements into actionable strategies for new product development and lifecycle management.
  • Joining ResMed offers a challenging career in a diverse and inclusive culture driven by excellence, where employees are encouraged to create new goals while making the world healthier.

Matching Summary

Match Score: 85

ResMed Pty is seeking an Advanced Specialist in Regulatory Product Strategy & Delivery to support their regulatory affairs function, particularly for software-driven and digital health solutions. The ideal candidate should have significant experience in regulatory affairs within the medical device sector, especially around Software as a Medical Device (SaMD) and relevant regulatory submissions.

Skills & Requirements

Must-have

  • Software as a Medical Device experience
  • FDA 510(k) submission authoring
  • EU MDR regulatory requirements knowledge
  • Product lifecycle regulatory assessments
  • Cross-functional team collaboration

Nice-to-have

  • AI/ML-enabled medical device experience
  • Agile software development environment familiarity
  • Cybersecurity and data privacy regulations
  • Global market access support experience
  • Mentoring junior staff capabilities

Key Requirements

  • Bachelor's degree required
  • Minimum 3 years regulated industry experience
  • Experience with FDA and EU MDR submissions
  • Background in digital health technologies

Work Rights

Not specified

Tailored Resume

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