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Compliance Engineer - Product Development

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ResMed

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Location:
Ireland; Canada , Dublin ▼

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Compliance Engineer will work with product engineering teams to ensure all regulatory and company requirements are met. The Compliance Engineering team is focused on ensuring Resmed's software products, and the processes used to develop them, are compliant with the latest safety, cybersecurity, and privacy standards and regulations.

Job Responsibility:

  • Lead critical design control activities including Safety risk analysis
  • Security risk analysis
  • Requirements traceability
  • Design review
  • SOUP/CSV management
  • Represent the team in audits, including medical device audits such as MDSAP and EU MDR and security audits such as HITRUST, SOC, and ISO 27001
  • Perform gap analyses to new and upcoming compliance standards and regulations
  • Make improvements to Resmed's Quality Management System procedures
  • Provide input on product regulatory strategy and be involved in communication with regulators and notified bodies

Requirements:

  • 2+ years of experience navigating technical products through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework
  • Proficiency in report writing, analysis, and compliance procedures
  • Thorough understanding of regulatory frameworks
  • Solid technical knowledge and understanding of product/process design
  • An understanding of Software Development Lifecycle

Nice to have:

  • B.S or M.S degree
  • At least 4 years of working in a regulatory environment in the healthcare industry
What we offer:
  • A supportive environment that focuses on people development and best practices
  • Opportunity to design, influence, and be innovative
  • Work with global teams and share new ideas
  • Be supported both inside and outside of the work environment
  • The opportunity to build something meaningful and seeing a direct impact on people's lives

Additional Information:

Job Posted:
February 18, 2026

Employment Type:
Fulltime
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