Compliance Engineer – Product Development
ResMed
full-time
Posted on:
Location Type: Hybrid
Location: Dublin • Ireland
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About the role
- 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
- B.S or M.S degree (Nice to Have)
- At least 4 years of working in a regulatory environment in the healthcare industry (Nice to Have)
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Safety risk analysisSecurity risk analysisRequirements traceabilityDesign reviewSOUP managementCSV managementReport writingCompliance proceduresRegulatory frameworksProduct/process design