Senior Compliance Engineer

ResMed

**
Samd development experience
Iso 13485 regulatory knowledge
Eu mdr compliance expertise
** ResMed is seeking a Senior Compliance Engineer to join their Digital Engineering Product Development team, focusing on compliance for Software as a Medical Device (SaMD) and health software applications. The role emphasizes collaboration with software engineering teams to ensure adherence to medical device regulations and cybersecurity standards, with a strong emphasis on risk management and compliance documentation. **

Job Summary

  • The role involves acting as the primary Subject Matter Expert for internal and external audits on medical device products.
  • Candidates will manage product requirement specifications and traceability matrices while leading technical design reviews.
  • The company offers a supportive environment focused on people development and the opportunity to build meaningful health technology solutions.

Matching Summary

Match Score: 75

** ResMed is seeking a Senior Compliance Engineer to join their Digital Engineering Product Development team, focusing on compliance for Software as a Medical Device (SaMD) and health software applications. The role emphasizes collaboration with software engineering teams to ensure adherence to medical device regulations and cybersecurity standards, with a strong emphasis on risk management and compliance documentation. **

Skills & Requirements

Must-have

  • SaMD development experience
  • ISO 13485 regulatory knowledge
  • EU MDR compliance expertise
  • Risk management plan creation
  • Medical device audits

Nice-to-have

  • Cybersecurity regulatory requirements
  • Global team collaboration
  • Innovation-driven culture
  • Clinical pathway understanding
  • Third-party software evaluation

Key Requirements

  • BS/MS in engineering or scientific discipline
  • 4-5 years medical device industry experience
  • 3-5 years experience with ISO 13485 and EU MDR
  • Proficiency in producing technical analysis reports

Work Rights

Not specified

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