Regulatory Affairs Specialist

1 month ago


Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time
About Us

At Device Technologies Australia Pty Ltd, we have a reputation for delivering high-quality medical solutions to hospitals and healthcare professionals across Australia, New Zealand, and Asia.

The Opportunity

We are seeking a skilled Regulatory Affairs Specialist to join our team. This is a critical role that involves working closely with internal and external stakeholders to ensure the quality, safety, and efficacy of our medical devices.

Responsibilities:
  • Manage a portfolio of medical devices, ensuring compliance with regulatory requirements in Australia and New Zealand.
  • Collaborate with cross-functional teams to solve problems related to regulatory affairs in the supply chain.
  • Develop and maintain relationships with ANZ regulators, including the TGA and Medsafe.
Requirements

To be successful in this role, you will require:

  • A strong understanding of Australian and New Zealand medical device regulations.
  • Experience working with Class I-IIb medical devices.
  • Excellent communication and problem-solving skills.
What We Offer

We offer a competitive salary of $90,000 - $110,000 per annum, depending on experience. Our benefits package includes:

  • A generous superannuation contribution.
  • A flexible work environment.
  • Ongoing training and professional development opportunities.
About Us

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