Quality and Regulatory Analyst

4 days ago

Macquarie Park New South Wales, Australia Dexcom Full time

Meet the team:

Join our dynamic and passionate team dedicated to making a difference in healthcare, specifically in the field of diabetes. Our Quality and Regulatory team is dedicated to ensuring the highest standards across our diabetes product portfolio. We work collaboratively across the organisation to meet all quality and regulatory requirements, from product launch and advertising through to post-market surveillance.

Where you come in:

  • You will coordinate tasks related to the Quality Management System (QMS), ensuring compliance with principal company requirements, Good Wholesaling Practice (GWP), and applicable regulatory frameworks, including implementation and maintenance of ISO 9001:2015.
  • You will assist with the quality operations of our 3PL warehouse, ensuring compliance with local regulations and corporate standards.
  • You will assist in developing and executing internal and external audit procedures to ensure continual compliance and quality improvement.
  • You will manage all aspects of pharmacovigilance and device vigilance activities for AMSL and NZMS, ensuring timely reporting and compliance.
  • You will review advertising and promotional materials to ensure alignment with local advertising codes and regulatory requirements.
  • You will support the preparation and submission of regulatory documentation to obtain and maintain product registrations in Australia and New Zealand
  • You will conduct reviews of relevant legislation and regulatory updates and manage product recalls in compliance with applicable codes/standards.
  • You will support onboarding and training of new employees in QMS procedures and related areas.
  • You will investigate and document quality issues and non-conformances, working cross-functionally to implement corrective and preventive actions.

What makes you successful:

  • You will have proven experience in developing and implementing ISO 9001:2015-compliant QMS.
  • You have knowledge of medical device registration processes with both Medsafe (NZ) and the TGA (Australia).
  • You have high attention to detail and strong analytical thinking.
  • You have excellent organisational and time management skills.
  • You have strong written and verbal communication.
  • You are proficient with Microsoft Office Suite (Outlook, Excel, PowerPoint, Word).

What you'll get:

  • A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
  • A full and comprehensive benefits program.
  • Growth opportunities on a global scale.
  • Access to career development through in-house learning programs and/or qualified tuition reimbursement.
  • An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

Travel Required:

  • 0-5%

Experience and Education Requirements:

  • Typically requires a Bachelor's degree and a minimum of 2-5 years of related experience
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