Regulatory Affairs Professional

14 hours ago


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

About Device Technologies Australia Pty Ltd...

Device Technologies Australia Pty Ltd is a leading supplier of medical solutions to hospitals and healthcare professionals in Australia, New Zealand, and Asia.

We have been dedicated to improving patients' lives through cutting-edge technology and services since 1992. Our reputation for quality, dedicated service, and ongoing support has grown over the past three decades.

Our Vision:

To ensure all our people feel valued, respected, and empowered to achieve their goals.

The Opportunity:

You will be responsible for a portfolio of medical devices, working closely with internal and external stakeholders to ensure high-quality products are delivered to customers. You will collaborate with cross-functional teams to solve regulatory affairs problems and maintain compliance with local requirements.

About You:

We seek a self-motivated problem solver who makes valuable connections within the business to understand customer and regulator needs. You should be driven by deadlines and take pride in exceeding targets while being passionate about delivering high-quality healthcare products to Australian and New Zealand patients.

Requirements:

  • A minimum of 3-5 years of experience working with the TGA in medical device regulatory submissions for Class I-IIb
  • A working knowledge of New Zealand medical device requirements
  • Experience solving regulatory-related problems in the supply chain and working with cross-functional teams representing regulatory affairs on projects

Salary: $95,000 - $120,000 per annum

Benefits:

We offer a comprehensive benefits package, including professional development opportunities, a dynamic work environment, and a competitive salary range.



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