Regulatory Affairs Associate

1 month ago


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

At Device Technologies Australia Pty Ltd, we are driven by a vision to improve patients' lives through innovative medical solutions.

We are seeking a highly skilled Regulatory Affairs Associate to join our team in Sydney. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and regulations for Class I-IIb medical devices.

With over 30 years of experience in providing high-quality medical solutions, we have developed a reputation for excellence in our industry. Our company culture is built on empowering our people to achieve their goals, aligning with wider business objectives.

The successful candidate will have a strong understanding of the Australian and New Zealand medical device regulatory environments. You will work closely with internal stakeholders to ensure the quality, safety, and efficacy of medical devices throughout their life cycle.

In this role, you will use your exceptional relationship skills to collaborate with ANZ regulators, the TGA, and Medsafe to demonstrate compliance of new products with local requirements. Your problem-solving skills and ability to work collaboratively with cross-functional teams will be essential in solving regulatory-related problems in the supply chain.

As a Regulatory Affairs Associate, you will be a self-motivated problem solver who makes valuable connections in all aspects of the business to understand customer and regulator needs. You are driven by deadlines and take pride in exceeding targets while being passionate about delivering high-quality healthcare products to Australian and New Zealand patients.

This is an excellent opportunity for a motivated and experienced professional to join our team and contribute to the success of our business. If you have a passion for regulatory affairs and a drive to succeed, we encourage you to apply for this role.

Please note that all qualified applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age, and other characteristics. We are committed to fostering an inclusive workplace culture that values and respects all employees.



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