Senior Specialist Regulatory Affairs

Senior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR\_043232**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.**Key Responsibilities****Regulatory Strategy & Execution:*** Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.* Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO and translate them into clear, well-supported regulatory documentation.* Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.**Product Change & Lifecycle Support:*** Lead regulatory assessments of design and process changes—performing significance evaluations and preparing documentation updates.* Provide regulatory input on system-level verification, biocompatibility, human factors, and labelling updates for high-volume products.* Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.**Cross-Functional Integration & Design Control Support:*** Represent RA in cross-functional design teams for products under Sydney legal manufacturer scope.* Engage early in project scoping and risk management activities to shape regulatory deliverables and timelines.* Act as a key point of contact for internal stakeholders on Sydney product regulatory requirements and interpretations.**Mentorship & Peer Enablement:*** Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration.* Support onboarding and documentation standardization across the Sydney RPSD team.* Contribute to process improvements and advocate best practices in tools like Jira, Confluence, and RIMSYS.**Qualifications & Experience****Required:*** Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.* 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).* Proven experience leading or coordinating global regulatory submissions (e.g., 510(k), CE Marking, TGA ARTG).* Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.* Excellent communication, project planning, and cross-functional influence skills.**Preferred:*** Prior experience working with ResMed-type devices (CPAP, ventilators, masks, accessories).* Familiarity with device-specific standards (e.g., ISO 17510, ISO , IEC 60601, ISO * Hands-on experience with submission platforms and document control tools (e.g., RIMSYS, Jira, Confluence).* Experience providing peer review or coaching in a cross-regional or matrixed environment.**Who You Are**You are a technical translator and regulatory mentor—someone who thrives in structured environments, applies high analytical rigor, and consistently delivers compliant, high-quality documentation. You bring people with you, clarify the complex, and help ResMed meet regulatory obligations while getting innovation to market faster.You understand that regulatory excellence is built not just on what you deliver—but how you support those around you to do the same.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
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