Senior Specialist Regulatory Affairs – Incubation

Job Summary 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. 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) The RPSD team leads regulatory strategy and delivery for physical and digital products. This includes non-device products and services that require regulatory consulting and analysis. The Incubation & Growth Team and Resmed is committed to developing a robust pipeline of innovative growth opportunities to expand and diversify Resmed's business. The scope encompasses enhancing growth accelerators within the current CAP and Respiratory Care business domains and diversifying into alternative therapies, adjacent sleep disorders, and beyond. This unique role contributes regulatory insights and cross-functional team support for projects initiated and led by the Incubation & Growth team. This role may also be involved in contributing to core business projects that are coordinated with the I&G team. Position Summary 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 look over a broad portfolio of products, many of which may not be medical devices products in all markets, understanding the nuance of such differences and providing the business with actionable strategies to support growth. 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 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 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation. Align closely 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. Collaborate with Engineering and Quality to resolve submission blockers and maintain lifecycle documentation compliance. Represent RA in cross-functional design teams for products and services led under I&G, working closely 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 on I&G team meetings as a business partner, understanding the business needs and bringing a regulatory point of view. 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 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 are able to 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 #J-18808-Ljbffr