Senior Global Labelling Architect

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

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.