The Digital Engineering Product Development organization is looking for a Senior Compliance Engineer to help develop SaMD (Software as a Medical Device) and health software applications for Resmed customers and patients.

Let's talk about the team and you:

As a Senior Compliance Engineer, you will work closely with our software engineering teams to shape both the design of our software products and the process for developing them to be compliant with applicable standards and regulations. You will be the go-to expert on medical device and cybersecurity regulatory requirements, ensuring that our products can be trusted by both regulators and our customers as safe, effective, and secure.

The role includes the following core responsibilities:

• Acting as primary SME (Subject Matter Expert) in internal and external audits for your assigned products
• Creating the Risk Management Plan and performing safety and security risk analysis in collaboration with the Software Engineering and Medical Affairs teams
• Managing product requirement specifications and traceability matrices
• Leading technical design reviews for new product introductions and product updates
• Producing robust release documentation to meet change management requirements
• Performing post-market risk assessments on product defects and incidents
• Evaluating third party software libraries and tools for inclusion in our software development
• Drafting gap analyses to new or updated regulations and standards
• Revising QMS procedures to improve compliance or efficiency of our processes

Let's talk about qualification and experience:

• BS/MS in any engineering or scientific discipline. Computer science preferred. No hands-on coding experience is needed.
• At least 4-5 years of working in the medical device or pharmaceutical industry, preferably in medical device product development.
• At least 3-5 years of experience in audits with criteria such as ISO 13485, EU MDR, MDSAP, HDS, SOC2, HITRUST and other regulatory frameworks.
• Proficiency in producing technical analysis/reports, including ability to learn about and understand clinical pathways.
• Thorough understanding of medical device regulations and standards.
• Solid technical knowledge of the software development lifecycle and common industry tools and methods.
• Basic familiarity with privacy laws (EU GDPR, CCPA, HIPAA)

Let's talk about what you can expect:

• 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.

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!

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.