Regulatory Affairs Specialist | Medical Devices | Orthopaedics

I'm partnering with an established international medical device company to identify an experienced Regulatory Affairs Specialist to join their Australian business.

The position offers location flexibility and can be based in Sydney, Melbourne or Adelaide, allowing us to consider strong RA/QA professionals across three of Australia's key medtech markets.

This is a fantastic chance for an RA professional who enjoys working in a hands-on workplace and wants to take ownership across regulatory and quality activities within a specialist medical device organisation.

The prospect:

You'll work closely with the Australian leadership team and international stakeholders, supporting regulatory compliance and quality activities across a portfolio of medical devices, with a particular focus on orthopaedics, including hip and knee products.

Key responsibilities will include:
Supporting Australian regulatory submissions and ongoing TGA / ARTG compliance




Managing regulatory documentation, product changes and registrations
Supporting CAPA, complaints, vigilance and post-market activities
Contributing to internal and external audits
Working within ISO 13485 requirements
Collaborating with local and international regulatory, quality and commercial teams

What we're looking for:
Experience within Regulatory Affairs in medical devices
Strong knowledge of TGA and Australian medical device regulations
Understanding of ISO 13485 and QMS requirements
Experience with higher-risk / implantable medical devices would be highly regarded
Previous exposure to orthopaedics, hip & knee, trauma, spine or surgical devices is a MUST
Strong communication skills and the ability to work effectively with both Australian and international stakeholders
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📌 Regulatory Affairs Specialist Melbourne (Australia)
🏢 Lead Group
📍 Australia