Regulatory Affairs Specialist
1 month ago
At Device Technologies Australia Pty Ltd, we have a reputation for delivering high-quality medical solutions to hospitals and healthcare professionals across Australia, New Zealand, and Asia.
The OpportunityWe are seeking a skilled Regulatory Affairs Specialist to join our team. This is a critical role that involves working closely with internal and external stakeholders to ensure the quality, safety, and efficacy of our medical devices.
Responsibilities:- Manage a portfolio of medical devices, ensuring compliance with regulatory requirements in Australia and New Zealand.
- Collaborate with cross-functional teams to solve problems related to regulatory affairs in the supply chain.
- Develop and maintain relationships with ANZ regulators, including the TGA and Medsafe.
To be successful in this role, you will require:
- A strong understanding of Australian and New Zealand medical device regulations.
- Experience working with Class I-IIb medical devices.
- Excellent communication and problem-solving skills.
We offer a competitive salary of $90,000 - $110,000 per annum, depending on experience. Our benefits package includes:
- A generous superannuation contribution.
- A flexible work environment.
- Ongoing training and professional development opportunities.
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