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Sydney, New South Wales, Australia
Onsite
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 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
Let's Talk About Qualifications & 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 experience required
What You Can Expect?
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?
With a 30 year history of innovation as a global leader in health technology, we know those good ideas can come from anywhere at 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. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.