Senior Labelling Specialist (Medical Devices)

Location: Sydney, NSW, Australia

Company

hirify.global develops medical devices and related healthcare solutions in a highly regulated environment.

What you will do

• Develop, maintain and manage medical device labelling, including user guides, clinical guides and product labels, across the product lifecycle.
• Translate regulatory, product, usability, manufacturing and market inputs into clear, verifiable and controlled labelling outcomes.
• Lead or contribute to regression testing, change-impact assessments, technical reviews, verification, validation and change documentation.
• Manage structured content in ELS/CCMS, support content migration, troubleshoot system issues and escalate defects.
• Coordinate localisation and translation workflows with external partners across global markets.
• Improve labelling processes, systems and governance while supporting approved automation and AI-enabled approaches.

Requirements

• Bachelor’s degree in a relevant science, engineering, regulatory or technical discipline, or equivalent experience.
• 5+ years of relevant experience in labelling, regulatory, quality, technical operations or a related discipline.
• Experience interpreting standards, procedures or regulatory requirements and translating them into controlled outputs.
• Experience managing structured or controlled content, traceability and change-control activities.
• Working knowledge of quality-system principles related to controlled documentation, change control and audit readiness.
• Strong written and verbal communication skills with the ability to collaborate across functions in a fast-paced environment.

Nice to have

• Experience in medical devices, healthcare or another regulated industry.
• Familiarity with structured authoring and content management platforms.
• Experience improving labelling workflows, tools or governance and conducting change-impact assessments.
• Experience coaching colleagues or building team capability.
• Experience using AI or automation to improve technical content workflows.

Culture & Benefits

• Work in a culture focused on excellence, inclusion, psychological safety and accountability.
• Contribute to a supportive environment that encourages individual expression, learning and growth.
• Collaborate with teams across hirify.global and communicate with working groups and senior stakeholders.