AMV (Alt. Myriad, Vapo) is a large, high-growth nicotine-replacement products group in Australasia, operating across wholesale distribution and retail channels. With deep industry expertise, vertically integrated capabilities, and a strong leadership team, we're accelerating Australasia's transition from combustible cigarettes to world-leading harm-reductive nicotine products.
Our market leadership spans 5,500+ retail outlets across New Zealand and Australia, supported by established brands, robust supply chain capabilities, and data-driven consumer insights.
About the Role
We are seeking an experienced Senior Regulatory Affairs Associate with strong expertise in New Zealand / Australian Medical Devices regulation to support regulatory strategy, submissions, and lifecycle compliance.
This role will focus primarily on Medical Devices (ARTG inclusions, variations, technical documentation, Essential Principles compliance), with working knowledge of S3/S4 medicines regulatory frameworks to support cross-category products where required.
Key Responsibilities
Medical Devices (Primary Focus)
Prepare and manage ARTG inclusion applications, variations, and change notifications.
Compile and maintain technical documentation in line with:
- Therapeutic Goods (Medical Devices) Regulations
- Essential Principles
- Relevant Australian and international standards
Conduct regulatory impact assessments for product changes.
Maintain device compliance throughout the product lifecycle.
Support post-market activities including vigilance and reporting obligations.
TGA Engagement & Regulatory Submissions
- Draft and coordinate responses to TGA requests for information.
- Support regulatory strategy for device submissions.
- Maintain regulatory records and compliance documentation.
- Monitor regulatory updates and advise stakeholders on changes impacting Medical Devices.
Medicines (S3/S4 – Supporting Scope)
Provide regulatory support for S3/S4 medicines including: