Dexcom

Quality and Regulatory Analyst

Dexcom

full-time

Posted on:

Location Type: Remote

Location: Australia

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About the role

  • Coordinate tasks related to the Quality Management System (QMS), ensuring compliance with principal company requirements, Good Wholesaling Practice (GWP), and applicable regulatory frameworks
  • Assist with the quality operations of our 3PL warehouse, ensuring compliance with local regulations and corporate standards
  • Assist in developing and executing internal and external audit procedures to ensure continual compliance and quality improvement
  • Manage all aspects of pharmacovigilance and device vigilance activities for AMSL and NZMS, ensuring timely reporting and compliance
  • Review advertising and promotional materials to ensure alignment with local advertising codes and regulatory requirements
  • Support the preparation and submission of regulatory documentation to obtain and maintain product registrations in Australia and New Zealand
  • Conduct reviews of relevant legislation and regulatory updates and manage product recalls in compliance with applicable codes/standards
  • Support onboarding and training of new employees in QMS procedures and related areas
  • Investigate and document quality issues and non-conformances, working cross-functionally to implement corrective and preventive actions

Requirements

  • Proven experience in developing and implementing ISO 9001:2015-compliant QMS
  • Knowledge of medical device registration processes with both Medsafe (NZ) and the TGA (Australia)
  • High attention to detail and strong analytical thinking
  • Excellent organisational and time management skills
  • Strong written and verbal communication
  • Proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint, Word)
Benefits
  • Flexible work arrangements
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 9001:2015quality management systempharmacovigilancedevice vigilanceaudit proceduresregulatory documentationproduct registrationcompliancequality improvementnon-conformance investigation
Soft Skills
attention to detailanalytical thinkingorganisational skillstime managementwritten communicationverbal communication