Senior Specialist Regulatory Affairs – Incubation

Senior Specialist Regulatory Affairs – Incubation & Growth The primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory strategies for portfolio planning, active regulatory intelligence and excellence in execution. Ensuring that systems and processes are established to enable ResMed to comply with multiple regulatory frameworks, in order to support the design, development and manufacture of products which meet our customer’s quality requirements. Working closely with all internal stakeholders and external regulators to achieve business goals. Overview As a Senior Specialist Regulatory Affairs – I&G, you will lead regulatory assessments and develop regulatory strategies for products and services that are led by the Incubation and Growth team. This role requires the ability to manage a broad portfolio of products, including those that may not be medical devices in every market, and to provide actionable strategies to support growth. You will collaborate across Regulatory Affairs, Engineering, Quality, and Operations, and mentor peers to ensure technical consistency and excellence in regulatory execution. Responsibilities Define regulatory strategies for I&G products and services. Author and review global regulatory submissions including FDA 510(K), CE MDR, TGA ARTG, and Health Canada dossiers for ResMed products (which may include masks, devices, or software). Interpret device-specific requirements (e.g., ISO 13485, ISO 14971, ISO 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation. Align closely with Regional Regulatory Affairs 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. Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance. Represent Regulatory Affairs in cross-functional design teams for I&G-led products and services, working with regional RA teams for input. 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. Sit in I&G team meetings as a business partner, understanding business needs and bringing a regulatory perspective. Mentor junior team members in regulatory interpretation, submission content quality, and cross-functional collaboration. Support onboarding and documentation standardization across the Sydney Regulatory Product Strategy & Delivery team. Contribute to process improvements and advocate best practices in tools like Jira, Confluence, and RIMSYS. Qualifications & Experience 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. 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. 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 are pragmatic and can bring people along, clarify the complex, and help ResMed meet regulatory obligations while delivering 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. #J-18808-Ljbffr