Senior Compliance Engineer

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. 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.

Core Responsibilities Act as primary SME (Subject Matter Expert) in internal and external audits for your assigned products Create the Risk Management Plan and perform safety and security risk analysis in collaboration with the Software Engineering and Medical Affairs teams Manage product requirement specifications and traceability matrices Lead technical design reviews for new product introductions and product updates Produce robust release documentation to meet change management requirements Perform post‑market risk assessments on product defects and incidents Evaluate third‑party software libraries and tools for inclusion in our software development Draft gap analyses of new or updated regulations and standards Revise QMS procedures to improve compliance or efficiency of our processes Qualifications & 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 experience 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, SOC 2, 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) What to 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 see a direct impact on people’s lives. #J-18808-Ljbffr