Regulatory Affairs Specialist | Medical Devices | Orthopaedics
I'm partnering with an established international medical device company to identify an experiencedRegulatory Affairs Specialistto join their Australian business.
The position offerslocation 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 opportunity for an RA professional who enjoys working in a hands-on environment and wants to take ownership across regulatory and quality activities within a specialist medical device organisation.
The opportunity:
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 onorthopaedics, including hip and knee products.
Key responsibilities will include:




Supporting Australian regulatory submissions and ongoingTGA / ARTG compliance
Managing regulatory documentation, product changes and registrations
SupportingCAPA, complaints, vigilance and post-market activities
Contributing to internal and external audits
Working withinISO *****requirements
Collaborating with local and international regulatory, quality and commercial teams
What we're looking for:
Experience withinRegulatory Affairs in medical devices
Robust knowledge ofTGA and Australian medical device regulations
Understanding ofISO ***** and QMS requirements
Experience with higher-risk / implantable medical devices would be highly regarded
Previous exposure toorthopaedics, 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
#J-*****-Ljbffr

📌 Regulatory Affairs Specialist (New South Wales)
🏢 Lead Group
📍 New South Wales