Senior Compliance Engineer

RESMED ASIA PACIFIC LIMITED

Not specified (assumed based on typical industry practices; further clarification may be needed).
Experience with medical device regulations
Risk management plan creation
Audit experience with iso 13485
ResMed Asia Pacific Limited is seeking a Senior Compliance Engineer to oversee compliance in the development of Software as a Medical Device (SaMD) and health software applications. The role involves collaborating with software engineering teams, conducting audits, and ensuring adherence to medical device regulations and standards

Job Summary

  • As a Senior Compliance Engineer, you will ensure our products are safe, effective, and secure.
  • You will act as the primary SME in internal and external audits for assigned products.
  • Join a supportive environment that focuses on people development and best practices.

Matching Summary

Match Score: 85

ResMed Asia Pacific Limited is seeking a Senior Compliance Engineer to oversee compliance in the development of Software as a Medical Device (SaMD) and health software applications. The role involves collaborating with software engineering teams, conducting audits, and ensuring adherence to medical device regulations and standards.

Skills & Requirements

Must-have

  • Experience with medical device regulations
  • Risk Management Plan creation
  • Audit experience with ISO 13485

Nice-to-have

  • Ability to work with global teams
  • Strong communication skills
  • Innovative mindset

Key Requirements

  • BS/MS in engineering or scientific discipline
  • 4-5 years in medical device industry
  • 3-5 years experience in audits

Work Rights

Not specified

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