Website Resmed
About ResMed
At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.
Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.
Team Overview
Regulatory Product Strategy & Delivery (RPSD) (Singapore). The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.
Position Summary
As a Specialist, Regulatory Product Strategy & Delivery â Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities for Singapore-manufactured devices and accessories. You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.
Key Responsibilities
- Regulatory Strategy & Execution: Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team. Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations. Contribute to authoring of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.
- Product Change Support: Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions. Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team. Track submission timelines and deliverables using Jira and other RA platforms.
- Cross-Functional Collaboration: Represent Regulatory Affairs
To apply for this job please visit resmed.wd3.myworkdayjobs.com.