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Quality, Regulatory and Sustainability Manager

New Zealand, Auckland · Job Posted February 19, 2026
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Job Description

We are seeking an experienced Quality, Regulatory and Sustainability Manager to join our team, leading quality, regulatory and ESG functions across our ANZ business. This is an autonomous role and is the primary contact for ANZ, working very closely with our global Quality and Regulatory (QARA) teams in EMEA and the APAC Regional Leadership Team. The Quality, Regulatory and Sustainability Manager is responsible for localising and embedding global quality systems, ensuring compliance with ISO: 13485, ISO:14001, TGA and Medsafe requirements, overseeing regulatory compliance and submission, leading ANZ audits, and championing continuous improvement and sustainability initiatives and strategies aligned with our global QARA and ESG objectives.

Job Responsibility

  • Own and continuously improve the ANZ ISO13485 QMS and related quality systems
  • Lead internal and external audits including local ANZ cross audits and ensure ongoing regulatory compliance
  • Manage complaints, CAPA, non-conformances, supplier quality and product risk
  • Act as the primary liaison with TGA, Medsafe and external compliance bodies ensuring compliance with requirements for medical devices, including listing/notification processes, post-market surveillance obligations, field safety notifications, incident reporting, and recalls
  • Oversee SOPs, document control and training
  • Lead ISO 14001 compliance and deliver the EcoVadis sustainability assessment
  • Drive sustainability initiatives and report on ESG performance
  • Partner with commercial, people, operational and global teams to build capability and embed quality and compliance

Requirements

  • A tertiary qualification in Quality, Science, Engineering or similar
  • 5+ years’ experience in quality and regulatory roles within medical devices or regulated industries
  • Strong knowledge of ISO 13485, ISO 14001, GDP and ANZ regulatory frameworks
  • Audit leadership experience and exposure to sustainability or ESG initiatives
  • Excellent communication, judgement, critical thinking and problem-solving skills
  • Experience with TGA, Medsafe and global QMS/WMS environments will be highly regarded

What we offer

  • Volunteer Leave
  • Free Flu Vaccinations
  • Flexible Working
  • Employee Assistance Programme
  • Life & Health Insurance

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