engineering
Posted May 8Compliance Engineer
at ResMed
Sydney, AustraliaOn-site
Responsibilities
- 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 Let's Talk About Qualifications &
- 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
- Experience: 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, ideally within product development At least 1 year of audit
- experience involving standards such as ISO 13485, EU MDR, MDSAP, HDS, SOC 2, HITRUST, or similar frameworks Strong ability to produce technical analyses and reports, with an aptitude for understanding clinical workflows and pathways Foundational knowledge of medical device regulations and standards Solid understanding of the software development lifecycle (SDLC), tools, and methodologies No hands-on coding
Additional details
- Role Summary: 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 that serve our customers and patients worldwide.
- In this role, you will collaborate closely with software engineering teams to ensure our products and development processes meet applicable regulatory, safety, and cybersecurity standards.
- As the subject matter expert, you will play a critical role in building trust with both regulators and customers by ensuring our solutions are safe, secure, and effective. Let's Talk About
- 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 Why ResMed?
- Innovation and imagination aren't just something we aspire to; they are integral to the way we work.
- We work hard to provide the opportunity for every employee to do amazing things every day as we shape the future together.
- Come play! #LI-APAC Joining us is more than saying “yes” to making the world a healthier place.
- It’s discovering a career that’s challenging, supportive and inspiring.
- Where a culture driven by excellence helps you not only meet your goals, but also create new ones.
- We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.