ABOUT RESMED

The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.
As an individual contributor in this team, the Regulatory Affairs Specialist will partner with cross-functional teams and global RA stakeholders to drive global submission readiness, change assessments, and technical documentation that meet diverse market requirements.
Team Overview : Regulatory Product Strategy & Delivery (RPSD) (Singapore)
The Sydney RPSD team leads regulatory strategy and submission execution for all physical products where ResMed Pty Ltd is the legal manufacturer—including masks, CPAP platforms, life-support ventilators, and accessories. The team operates across New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) to enable timely, compliant market access.
As a Senior Specialist, you will play a critical role in authoring and reviewing submissions, guiding change assessments, and mentoring team members on the application of global regulations to high-volume, technically complex products.

POSITION SUMMARY

As a Senior Specialist Regulatory Affairs – Sydney, you will lead submission planning and execution, influence design documentation, and contribute to regulatory strategy for ResMed’s core portfolio of Sydney-manufactured devices.
You will be a key contributor to product change assessments and will collaborate across Regulatory Affairs, Engineering, Quality, and Operations. You’ll also serve as a mentor to peers, ensuring technical consistency, clarity, and excellence in regulatory execution.