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Compliance Engineer

resmed.com Logo

ResMed

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Location:
United States , San Diego

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

91000.00 - 113000.00 USD / Year
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Job Description:

The Compliance Engineer will work with software development teams to ensure all regulatory and company requirements are met.

Job Responsibility:

  • Act as SME for all the audits for ResMed's digital products. Represent ResMed Engineering in audits, including but not limited to HDS, MDSAP, SOC2, and MDR
  • Identify and evaluate technical design alternatives to achieve desired functionality in partnership with cross-functional team members and Systems Architecture Leaders
  • Educate the engineering teams on the design review needs and facilitate the design review process among those teams
  • Enhance or modify existing design review processes
  • Help resolve technical issues
  • Drive the bug-triage process and help determine issues that impact patient safety
  • Participate in the product roadmaps and influence the release of features based on safety risk analysis
  • Act as a bridge between Product Engineering and ResMed Quality/Regulatory teams and bring knowledge on the latest safety-related standards
  • Tackle intrinsically challenging problems with implication to regulatory requirements from around the world
  • Ensure the company's technical compliance with applicable laws and regulations
  • Collaborate with engineers and designers to deliver compliant products and services
  • Responsible for researching and identifying applicable regulatory and industry compliance standards and codes
  • Ensure product achieves performance, functionality and reliability as specified in the marketing and systems specification documents
  • Act as SME for formal releases to ensure meeting all the needed compliance and regulatory-related deployment documentation
  • Prepare compliance reports by collecting, analyzing, and summarizing measurement data and trends related to post-launch market data

Requirements:

  • BS/MS in any engineering discipline. Computer science preferred
  • No hands-on coding experience is needed
  • Working knowledge of regulations including but not limited to MDSAP, ISO13485:2016, IEC62304, SOC2 controls
  • 3 years of experience delivering medical products and navigating through audits like MDR, SOC2, MDSAP, HDS, or any other regulatory framework is a plus
  • Proficiency in report writing, analysis, and compliance procedures
  • Thorough understanding of regulatory frameworks
  • Solid technical knowledge and understanding of Software Product Life Cycle (SDLC)
What we offer:
  • comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
  • fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members

Additional Information:

Job Posted:
February 20, 2026

Employment Type:
Fulltime
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