Senior Compliance Engineer

ResMed

**
Medical device regulatory compliance
Iso 13485 eu mdr mdsap audit experience
Risk management plan creation
** ResMed is seeking a Senior Compliance Engineer to enhance the development of software as a medical device (SaMD) and health applications. The role focuses on ensuring compliance with regulatory standards and involves collaboration with engineering teams to maintain product safety and security. **

Job Summary

  • The role involves acting as the primary Subject Matter Expert for internal and external audits on assigned 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.

Matching Summary

Match Score: 75

** ResMed is seeking a Senior Compliance Engineer to enhance the development of software as a medical device (SaMD) and health applications. The role focuses on ensuring compliance with regulatory standards and involves collaboration with engineering teams to maintain product safety and security. **

Skills & Requirements

Must-have

  • Medical device regulatory compliance
  • ISO 13485 EU MDR MDSAP audit experience
  • Risk management plan creation
  • Software development lifecycle knowledge
  • Third-party library security evaluation

Nice-to-have

  • Clinical pathway understanding
  • Privacy law familiarity GDPR HIPAA
  • Global team collaboration experience
  • Innovation-driven culture fit

Key Requirements

  • BS/MS in engineering or scientific discipline
  • 4-5 years medical device industry experience
  • 3-5 years experience with ISO 13485 EU MDR audits
  • No hands-on coding experience required

Work Rights

Not specified

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