Compliance Engineer

The Digital Engineering Product Development team at ResMed is seeking a Compliance Engineer to support the development of Software as a Medical Device (SaMD) and health software applications. The role involves collaborating with software engineering teams to ensure products meet regulatory, safety, and cybersecurity standards, and serving as the subject matter expert during internal and external audits.

Requirements

• 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
• 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

Benefits

• A supportive and collaborative environment focused on professional development and best practices
• 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
• The chance to contribute to meaningful solutions that positively impact people's lives