Compliance Engineer

Responsibilities

• Serve as the primary Subject Matter Expert (SME) during internal and external audits for assigned products
• Develop Risk Management Plans and perform safety and cybersecurity risk analyses in collaboration with Software Engineering and Medical Affairs teams
• Manage product requirement specifications and maintain traceability matrices
• Lead technical design reviews for new product introductions and product enhancements
• Prepare comprehensive release documentation to support change management requirements
• Conduct post-market risk assessments on product defects and incidents
• Evaluate third-party software libraries and tools for integration into development workflows
• Perform gap analyses against new or updated regulations and industry standards
• Update and improve Quality Management System (QMS) procedures to enhance compliance and operational efficiency

Requirements

• Bachelor’s or Master’s degree in Engineering or a scientific discipline (Computer Science preferred)
• 2–3 years of experience in the medical device or pharmaceutical industry
• At least 1 year of audit experience involving standards such as ISO 13485, EU MDR, MDSAP, HDS, SOC 2, or HITRUST
• Foundational knowledge of medical device regulations and standards
• Solid understanding of the software development lifecycle (SDLC), tools, and methodologies
• Strong ability to produce technical analyses and reports

Benefits

• Supportive and collaborative environment focused on professional development
• Opportunities to design, influence, and innovate within a global health technology organization
• Collaboration with cross-functional and global teams
• A workplace that promotes both professional and personal well-being

About the Company

ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices, and intelligent software make home healthcare more personalized, accessible, and effective.