Senior Labelling Specialist
resmed · Sydney
Job description
About the role
Join ResMed’s Labelling Centre of Excellence to design global labelling that turns complexity into clear, compliant messaging. You will be the technical specialist responsible for developing and maintaining medical device labelling throughout the product lifecycle.
Key responsibilities
- Translate regulatory, product, usability and manufacturing inputs into accurate, verifiable labelling outcomes.
- Lead or contribute to regression and change‑impact assessments when standards or product requirements change.
- Create, maintain and manage labelling content using legacy and enterprise systems, applying structured‑content principles in ELS/CCMS.
- Ensure labelling decisions are consistent, traceable and auditable, supporting quality and verification activities.
- Coordinate with external partners for localisation and translation workflows.
- Identify and implement improvements to labelling processes, tools and ways of working.
- Support content migration, troubleshoot ELS/CCMS issues and evaluate AI‑enabled automation approaches.
- Share technical knowledge, coach colleagues and build team capability.
Required profile
- Bachelor’s degree in a relevant science, engineering, regulatory or technical discipline, or equivalent experience.
- 5+ years of experience in labelling, regulatory, quality or technical operations.
- Proven ability to interpret standards and regulatory requirements into controlled outputs.
- Working knowledge of quality‑system principles for controlled documentation and audit readiness.
- Strong written and verbal communication skills and ability to collaborate across functions.
Required skills
- Structured content creation and management using ELS/CCMS.
- Change‑control and traceability processes for controlled documentation.
- Regulatory and quality‑system knowledge relevant to medical device labelling.
- Experience with AI or automation tools to improve technical content workflows.
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Published 19 hours ago
Expires 1 month from now
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resmed
Sydney
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