Senior Specialist Regulatory Affairs

The Sydney Regulatory Affairs team leads regulatory strategy and submission execution 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. The Regulatory Affairs Specialist partners with cross-functional teams and global RA stakeholders to drive global submission readiness, change assessments, and technical documentation that meet diverse market requirements.

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 collaborate across Regulatory Affairs, Engineering, Quality, and Operations, and mentor peers to ensure technical consistency and excellence in regulatory 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 13485, ISO 14971, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation.
• Align with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.
• 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 labeling updates for high-volume products.
• Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance.
• 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.
• 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.

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 80601-2-70, IEC 60601, ISO 18562).
• 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.

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 bringing innovation to market faster.