Job Description

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ABOUT THE ROLE

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We are seeking an enthusiastic and collaborative Regulatory Affairs Associate to join our Australia and New Zealand Regulatory Affairs team. This is an opportunity for an early-career skilled to develop regulatory expertise across a broad range of therapies and innovative medical technologies with a global medical technology leader.

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Working closely with the ANZ Regulatory Affairs Manager and broader Regulatory Affairs team, you will support the preparation and submission of regulatory applications to Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe, help maintain existing product registrations and support ongoing compliance with applicable regulatory requirements.

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This role is based in Mascot, Sydney and will report to the Regulatory Affairs Manager.

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KEY RESPONSIBILITIES

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Regulatory Knowledge and Application

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- Support preparation and submission of regulatory applications to the TGA and Medsafe.

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- Maintain existing product registrations throughout their lifecycle.

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- Support regulatory strategies for product introductions and changes.

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- Review promotional materials for compliance with applicable regulations and industry codes.

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- Maintain accurate regulatory documentation and records.

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- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures

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- Explore and utilise AI, automation and digital technologies to support process improvements and enhance productivity.

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- Contribute to a culture of continuous improvement by challenging existing processes, recommending innovative solutions, and supporting the implementation of sustainable improvements across the business.

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