Regulatory Affairs Specialist

3 weeks ago

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

About Device Technologies Australia Pty Ltd...

We are dedicated to improving patients' lives through leading edge technology and services, supplying hospitals and healthcare professionals with high-calibre medical solutions from around the world.

Our culture is built on empowering our people to achieve their goals, aligning with wider business objectives. We focus on productivity, continuous improvement, career development and leadership nurturing to foster a superior workforce.

Key Responsibilities:

  • Ensure a high level of quality, safety and efficacy is assured throughout the life cycle of medical devices.
  • Work with cross-functional internal teams to solve problems related to regulatory affairs in the supply chain.
  • Use exceptional relationship skills with ANZ regulators, the TGA and Medsafe, to demonstrate compliance of new products with local requirements.

Requirements:

  • 3-5 years Australian experience working with the TGA in medical device regulatory submissions for Class I-IIb.
  • Working knowledge of the 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.

At Device Technologies, we succeed through our commitment to four key values:

Delivering Innovation - We encourage and reward fresh ideas and are committed to supporting our people to make change.

Seeking Collaboration - We support each other in our combined mission to help others achieve their goals.

Taking Ownership - We believe in equipping our people to take responsibility and accountability in their roles and trust them to get the job done.

Practising Good Business - Our success is built on a mix of intuition and experience and we foster an environment where all voices are heard and nobody is afraid to make mistakes.

We are looking for a self-motivated problem solver who makes valuable connections in all aspects of the business to understand customer and regulator needs, matching the two to provide access to devices in the target region.

Our ideal candidate is passionate about the delivery of high-quality healthcare products to Australian and New Zealand patients.

We are an equal opportunities employer and welcome applications from diverse candidates.

For more information, please click on the 'apply' button.

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