Regulatory Affairs Associate

6 days ago


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

About Device Technologies Australia

Device Technologies Australia is a leading medical device supplier dedicated to improving patients' lives through innovative technology and services. With a strong commitment to quality, safety, and efficacy, we supply hospitals and healthcare professionals with high-calibre medical solutions from around the world.

Our Culture

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.

The Opportunity

We are seeking a highly motivated and experienced Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs team, you will be responsible for a portfolio of medical devices, working closely with internal and external stakeholders to ensure a high level of quality, safety, and efficacy is assured throughout the life cycle.

Key Responsibilities

  1. Collaborate with cross-functional internal teams to solve problems related to regulatory affairs in the supply chain.
  2. Work with ANZ regulators, the TGA, and Medsafe to demonstrate compliance of new products with local requirements.
  3. Develop and maintain strong relationships with internal and external stakeholders to ensure effective communication and collaboration.
  4. Stay up-to-date with regulatory requirements and changes, ensuring compliance and providing guidance to the team.

About You

We are looking for a self-motivated problem solver who is passionate about delivering high-quality healthcare products to Australian and New Zealand patients. You will be a strong communicator with excellent relationship-building skills, able to work effectively in a fast-paced environment.

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.

What We Offer

At Device Technologies Australia, we offer a dynamic and supportive work environment, with opportunities for career growth and development. We are committed to fostering a culture of innovation, collaboration, and excellence, and we are looking for like-minded individuals to join our team.



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