Lead Labelling Specialist (Medical Devices)

Location: Sydney, NSW, Australia

Company

hirify.global develops medical devices and related technologies, with a focus on improving healthcare and product experiences through regulated, customer-focused solutions.

What you will do

• Own the most complex, ambiguous, and high-impact medical device labelling challenges across the product lifecycle.
• Shape end-to-end labelling system architecture, including workflows, decision points, interfaces, and escalation pathways.
• Provide technical leadership on labelling regulations, standards, guidance, localisation, and translation across global markets.
• Lead improvements to processes, templates, structured content, tooling, content migration, and ELS/CCMS capabilities.
• Strengthen governance for requirements interpretation, traceability, controlled documentation, change control, verification, and validation.
• Mentor colleagues, lead complex escalations, communicate recommendations and risks, and influence senior cross-functional stakeholders.

Requirements

• Deep technical knowledge of medical device labelling regulations, standards, and guidance.
• Bachelor’s degree in a relevant science, engineering, regulatory, or technical discipline, or equivalent relevant experience.
• 8+ years of relevant experience in labelling, regulatory, quality, technical operations, or a related discipline.
• Demonstrated experience solving complex labelling or regulatory problems and leading process, governance, or system-level improvements.
• Experience with controlled documentation, traceability, change control, audit readiness, and risk-based decision-making in regulated environments.
• Strong stakeholder management, influencing, communication, and senior-level presentation skills.

Nice to have

• Experience in medical devices, healthcare, or another regulated industry.
• Familiarity with enterprise labelling and structured-content systems such as ELS/CCMS, including migration or change-adoption initiatives.
• Experience developing technical capability, coaching colleagues, or building influence across a function.
• Experience with global markets, differing regulatory requirements, and AI or automation use cases in regulated technical-content workflows.
• Advanced degree in a relevant technical, regulatory, or scientific discipline.

Culture & Benefits

• Work in a challenging, supportive, and inspiring environment focused on excellence.
• Contribute to a diverse and inclusive culture that encourages individual expression and innovative ideas.
• Help build psychological safety, accountability, continuous learning, and professional growth.
• Collaborate across regulatory, quality, engineering, operations, UX, and other functions.