Regulatory Affairs Specialist

3 days ago

Sydney, New South Wales, Australia Stryker Full time

Based in Australia, this Senior Regulatory Affairs Associate role at Stryker presents an exciting opportunity to join a high-performing team in the medical device industry. With a strong focus on regulatory compliance, you will be responsible for preparing and submitting device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications.

The ideal candidate will have a minimum of 5 years' experience in a similar Regulatory Affairs role, with a strong background in medical devices and regulatory affairs. A tertiary education in a technical discipline (e.g., Science, Engineering, Biomedical or related) is also required. Additionally, you will possess excellent attention to detail, deadline-oriented skills, and the ability to thrive in a fast-paced environment.

In this role, you will work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe, and Corporate requirements. You will also be responsible for managing annual reports and renewal of licenses to ensure compliance with local regulatory requirements.

A key aspect of this position is providing strategic regulatory advice and transfer management for smooth incorporation of product acquisitions. You will also develop new regulatory processes and continuous process improvements, ensuring corporate compliance by supplying information as required by the TGA and Medsafe.

This is a fantastic opportunity for someone looking to step up their career in Regulatory Affairs, with opportunities for professional growth and development within a leading company in the medical device industry.

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