Senior Compliance Engineer

Job description

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 do...