Senior Labelling Specialist

Job description

“Design global labelling that transforms complexity into clear and compliant messaging, creating confidence and elevating the product experience.” That’s the mission of the ResMed Labelling Centre of Excellence. We partner with teams across ResMed to translate regulatory, product, usability, manufacturing and market inputs into accurate, controlled and customer-focused labelling. In a highly regulated environment, attention to detail, traceability and sound judgement are essential to supporting product safety, quality and timely delivery. About the role As a Senior Labelling Specialist , you will be a hands-on technical specialist responsible for developing and maintaining medical device labelling - user guides, clinical guide, labels and more - across the product lifecycle. You will work within established quality, regulatory and governance frameworks to deliver clear, accurate and traceable labelling outcomes. You will apply a practical, risk-based approach to complex requirements, identify and escalate risks appropriately, and collaborate across functions to resolve issues and support timely decisions. You will also help strengthen the capability of the team by sharing technical knowledge, coaching colleagues and contributing to continuous improvement in labelling processes, systems and ways of working. You lift the people around you. You build trust and contribute to a culture of psychological safety and accountability, where people feel confident to contribute, challenge, learn and grow. Let’s talk about Responsibilities Translate requirements into labelling outcomes. Interpret upstream regulatory, product, usability, manufacturing and other approved source inputs and translate them into clear, verifiable labelling outcomes. Assess change impact. Lead or contribute to regression and change-impact assessments when applicable standards, approved source information, products or labelling requirements change. Manage controlled labelling content. Create, maintain and manage labelling content using applicable legacy and enterprise systems, applying structured-content principles in ELS/CCMS. Strengthen governance. Keep labelling decisions consistent, traceable and auditable, with standards applied the same way every time Support quality and verification. Lead or contribute to technical reviews, change documentation, verification and validation activities, supporting the completeness, accuracy and regulatory alignment of labelling deliverables. Manage issues and dependencies. Work functions to resolve issues, identify risks and dependencies, communicate impacts and escalate matters requiring broader or higher-level decisions. Support global labelling. Coordinate with external partners to support localisation and translation workflows in accordance with applicable procedures and market requirements. Improve how we work. Identify and implement practical improvements to labelling processes, tools and ways of working that improve quality, consistency, efficiency and cycle time. Support labelling systems. Contribute to content migration and system improvement activities, troubleshoot ELS/CCMS issues and escalate system defects through the right channels. Push the edge. Evaluate, use and support approved digital, automation and AI-enabled approaches that may improve content quality, consistency or efficiency, in accordance with applicable quality, regulatory, privacy, security and governance requirements. Build team capability. Share technical knowledge, coach colleagues on tools, standards and good practices, and support onboarding and capability development. Communicate effectively. Present technical information, recommendations, risks and decisions clearly to any audience, from working teams and senior stakeholders. Let’s talk about you You’ll bring: A bachelor’s degree in a relevant science, engineering, regulatory or technical discipline, or equivalent relevant experience. 5+ years of relevant experience in labelling, regulatory, quality, technical operations or a related discipline. Demonstrated experience interpreting standards, procedures or regulatory requirements and translating them into practical, controlled outputs. Experience creating or managing structured or controlled content, including traceability and change-control activities. Working knowledge of quality-system principles relevant to controlled documentation, change control and audit readiness. Strong written and verbal communication skills and demonstrated ability to collaborate effectively across functions. Comfort in a fast-paced environment where quality, traceability and timely delivery all matter. Preferred experience It would be beneficial if you also bring: Experience in medical devices, healthcare or another regulated industry. Experience conducting regression or change-impact assessments or managing controlled-document changes across a product lifecycle. Familiarity with structured authoring and content management platforms. Experience improving labelling or similar operational workflows, tools or governance. Experience coaching colleagues or building capability within a team. Familiarity with labelling requirements across multiple global markets. Using AI or automation to improve technical content workflows. #LI-APAC 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! We commit to respond to every applicant.