Regulatory Affairs Professional

5 days ago


Sydney, New South Wales, Australia Dexcom Inc. Full time

About Dexcom Inc.

Dexcom, a leading global developer of continuous glucose monitoring (CGM) technology, is dedicated to transforming diabetes care and management. We are passionate about introducing advances in healthcare and science for the benefit of patients and healthcare providers.

This position offers a unique opportunity to be part of a highly skilled team responsible for navigating regulatory requirements across Australia and other APAC countries.

Key Responsibilities:

  • Collaborate with regulatory representatives to develop and implement regulatory strategies
  • Prepare and submit regulatory documentation, including product labeling and advertising materials
  • Provide technical guidance on regulatory requirements and assess the impact of new regulations
  • Support internal and external audits, ensuring compliance with medical device regulations

Requirements:

  • Knowledge of Australian, New Zealand, and international medical device regulations, including submission requirements and quality systems
  • Experience with regulatory submissions in Australia and New Zealand
  • Strong analytical and problem-solving skills, with excellent communication and technical writing abilities

  • regulatory affairs

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