regulatory-affairs

  • Experienced and qualified professionals provide expertise for our diverse range of medical devices and complexity of associated regulations
  • Ensure regulatory compliance with all relevant legislation
  • Maintain over 900 medical device registrations
  • Liaise with government departments, health funds and various industry bodies
  • Assist hospital administrators and healthcare professionals with documentation and other queries
  • Prepare and submit regulatory applications in a timely and cost effective manner to facilitate the introduction of new products and new agencies to the healthcare market
  • Provide advice on Code of Practice issues such as interactions with healthcare professionals, endorsements & donations etc
  • Member of Trace International: non-profit organisation that provides anti-bribery compliance for multinational companies and their commercial intermediaries

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