Lead Labelling Specialist

Medifox DAN GmbH; Sydney; On-site; AUD 140,000 - 190,000; Full time

Job summary

ResMed's Labelling Centre of Excellence in Sydney is seeking a Lead Labelling Specialist to own the most complex medical device labelling challenges across the product lifecycle.

You will apply deep regulatory expertise, governance, and systems thinking to shape workflows, templates and tooling (ELS/CCMS), delivering compliant, scalable outcomes.

You will mentor and influence peers, partner with regulatory, quality and engineering teams, and drive continuous improvement in a regulated environment.

Qualifications

• Deep technical knowledge of medical device labelling regulations and guidance.
• Bachelor's degree in a relevant field or equivalent experience.
• 8+ years of experience across labelling, regulatory, quality or related discipline.
• Experience solving complex, ambiguous or high-impact labelling or regulatory problems.
• Experience leading governance, standards, or system-level improvements with multiple stakeholders.
• Strong stakeholder management and communication with senior stakeholders.

Responsibilities

• Solve the hardest labelling problems with direct ownership.
• Shape the end-to-end labelling system architecture across the product lifecycle.
• Set the technical direction for interpretation and application of labelling regulations.
• Develop improved processes and tooling (ELS/CCMS).
• Lead complex escalations with risk-based judgement.
• Align with regulatory, quality, engineering and operations leaders.
• Strengthen governance across traceability, change control and verification/validation.
• Shape global labelling including localisation and translation efforts.
• Lead continuous-improvement and broader system initiatives.
• Mentor team members and build technical capability.

Skills

Labelling regulations knowledge

Stakeholder management

Technical leadership

Regulatory judgement

Communication skills

Education

Bachelor's degree or equivalent

Tools

ELS/CCMS

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 Lead Labelling Specialist, you will be a hands-on technical authority responsible for solving the most complex, ambiguous and high-impact medical device labelling challenges across the product lifecycle. You will combine deep labelling and regulatory expertise with systems thinking to help shape how labelling processes, governance, technology and information work together.

You will apply a practical, risk-based approach to complex requirements and decisions, bringing together the right expertise, identifying and escalating risks appropriately, and working across functions to reach clear, timely and defensible outcomes.

You will work closely with Labelling leadership to help shape the technical direction and evolution of the labelling function, strengthening its processes, systems and governance as ResMed’s products, technologies and business evolve.

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. Through your technical leadership and influence, you help others build the judgement and capability to solve increasingly complex problems.

Let’s talk about what you’ll do

• Solve the hardest problems. Take direct, hands-on ownership of the most complex, ambiguous and high-impact labelling challenges – working in the detail and partnering with labelling leadership on the approach to the toughest ones.
• Shape the labelling system. Partner with Labelling leadership shape the end-to-end labelling system architecture – workflows, decision points, interfaces, and escalation pathways across the product lifecycle.
• Set the technical direction. Provide technical leadership on the interpretation and application of labelling regulations, standards, guidance and requirements, helping drive clear, consistent and scalable approaches across products and markets.
• Build the future state. Lead the technical development and implementation of improved processes, templates, structured-content approaches and tooling (including ELS/CCMS), simplifying the operating model and improving quality, cycle time and control.
• Lead complex escalations. Act as a senior technical escalation point for complex labelling matters, bringing together the right stakeholders and expertise and applying risk-based judgement to support timely, documented and defensible decisions.
• Align the business. Partner with leaders across regulatory, quality, engineering, operations, UX and beyond on process design, timing and change impact.
• Strengthen governance. With labelling leadership, define how requirements interpretation, structured-content governance, traceability, and verification and validation work across the lifecycle.
• Shape global labelling. Provide technical leadership for localisation and translation approaches that support consistent and scalable delivery across global markets.
• Improve how we work. Partner with labelling leadership to prioritise, sponsor and lead continuous-improvement and broader system initiatives that make the function perform better and stand up to change.
• Shape labelling systems. Provide technical leadership for the evolution of labelling systems and structured-content capabilities, including ELS/CCMS, content migration and broader system improvements.
• Push the edge. Evaluate, champion and help scale 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. Mentor and develop team members, strengthening technical judgement, professional maturity and a culture of continuous learning.
• Communicate and influence. Present complex technical information, recommendations, risks and decisions clearly and credibly to any audience, including senior stakeholders, and represent Labelling in cross-functional forums.

Let’s talk about you

You’ll bring:

• Deep technical knowledge of medical device labelling regulations, standards and guidance, together with demonstrated judgement in applying them to complex, real-world situations.
• A bachelor’s degree in a relevant science, engineering, regulatory or technical discipline, or equivalent relevant experience.
• 8+ years of relevant experience across labelling, regulatory, quality, technical operations or a related discipline, with substantial experience in complex cross-functional environments.
• Demonstrated experience personally solving complex, ambiguous or high-impact labelling or regulatory problems.
• Demonstrated experience leading process design, standards governance or system-level improvements involving multiple stakeholders.
• Experience shaping or applying governance for controlled documentation, traceability, change control and audit readiness in regulated environments.
• Strong stakeholder management, influencing and communication skills, including the ability to build credibility with senior stakeholders.
• Demonstrated ability to apply sound, risk-based judgement when requirements, evidence or stakeholder perspectives are complex or incomplete.

Preferred experience

It would be beneficial if you also bring:

• Experience in medical devices, healthcare or another regulated industry.
• Experience shaping end-to-end process architecture, operating models or governance frameworks.
• 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 working across global markets with differing regulatory or labelling requirements.
• Experience establishing or scaling AI or automation use cases within regulated technical-content workflows.
• An advanced degree in a relevant technical, regulatory or scientific discipline.

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