Head of Quality and Regulatory Affairs

Location: Melbourne, Victoria
Job Type: Permanent / Full Time
Contact: Tim Barraclough

About the Company

Our client has the largest market share in the global dental prosthetic devices sector and has an impressive global portfolio of brands across Europe, USA, Canada, and the APAC regions.

About the Role

With the growth of the Australian market, they are looking to implement ISO 13485 in all Australian and NZ locations. As Head of Quality and RA, you will be responsible for the overall development, implementation, and maintenance of the QMS, and maintaining regulatory compliance for all products, including TGA and ARTG listings.

About You

Ideally you will have at least 5 years + experience in Quality Management within the medical device sector, preferably within a manufacturing setting. You will need a solid track record of establishing and writing the quality documentation to meet the current TGA and Medsafe standards, developing the compliance framework, and implementing the performance indicators. You will oversee product registrations, conduct audits, and promote "best practice" within the organisation nationally. You will lead from the front, and have superior communication skills, stakeholder engagement and be passionate about compliance. With the largest manufacturing hub in Melbourne, there will be frequent travel between major capital cities including New Zealand.


In return, you will be rewarded with an attractive salary package, be part of an impressive leadership team, and have the opportunity to drive change and innovation.

How to Apply

For more confidential information please call Tim on 0422076399 or Sandy on 0413133255, or click on the link to apply