Compliance Engineer

ResMed

Base: $91,000 - $113,000 usd; bonus/equity: not sp...
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Bs/ms in engineering or computer science
Working knowledge of mdsap and iso13485:2016
Understanding of iec62304 and soc2 controls
** ResMed is seeking a Compliance Engineer to enhance product compliance and audit processes within its Digital Product Engineering team, focusing on improving patient outcomes through digital experiences. The role involves ensuring that the company's offerings meet local and international regulatory standards, collaborating with cross-functional teams, and providing input during the product development lifecycle. **

Job Summary

  • The Compliance Engineer will act as the subject matter expert for audits including HDS, MDSAP, SOC2, and MDR for ResMed's digital products.
  • This role requires driving safety risk analysis to determine issues impacting patient safety and influencing feature releases based on those findings.
  • Employees are eligible for a comprehensive benefits package including medical, vision, dental, life insurance, 401(k), and fifteen days of Paid Time Off.

Matching Summary

Match Score: 75

** ResMed is seeking a Compliance Engineer to enhance product compliance and audit processes within its Digital Product Engineering team, focusing on improving patient outcomes through digital experiences. The role involves ensuring that the company's offerings meet local and international regulatory standards, collaborating with cross-functional teams, and providing input during the product development lifecycle. **

Salary

Base: $91,000 - $113,000 USD; Bonus/Equity: Not specified; Benefits: Comprehensive medical, vision, dental, life, AD&D, disability, HSA, FSA, commuter benefits, 401(k), ESPP, EAP, tuition assistance

Skills & Requirements

Must-have

  • BS/MS in engineering or computer science
  • Working knowledge of MDSAP and ISO13485:2016
  • Understanding of IEC62304 and SOC2 controls
  • Experience with MDR, HDS, or similar audits
  • Proficiency in report writing and compliance procedures

Nice-to-have

  • Sound technical background in software lifecycle
  • Ability to drive bug-triage processes
  • Experience influencing product roadmaps
  • Strong communication skills for cross-functional teams

Key Requirements

  • 3 years experience delivering medical products
  • Navigating through MDR, SOC2, MDSAP, or HDS audits
  • Thorough understanding of regulatory frameworks
  • Solid technical knowledge of Software Product Life Cycle

Work Rights

Not specified

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