Senior Regulatory Affairs

We are looking for an experienced Regulatory Affairs professional with experience with Medical Devices.

The Company
Our client is a world leading, publicly listed Australian company which develops biosensors for application across the globe.
The role
We are looking for an experienced Senior Regulatory Affairs Specialist who has regulatory experience with medical devices. This role can be a permanent full-time or part-time position based in the vibrant Rowville area of Melbourne. Their biosensor technology is used for blood glucose monitoring and blood coagulation in diabetes patients worldwide.
Responsibilities

• To develop a clear global regulatory strategy for all product development and commercialisation plans.
• Lead product regulatory approval projects across Australia, EU and the US.
• Prepare and maintain medical device files for submission to regulatory authorities across the globe.
• To communicate with regulatory agencies.
• Provide input on PMS, including alignment to FDA, TGA and EU IVDR.

The Candidate

• Tertiary qualification in Life Sciences/Medical/Engineering or similar.
• Experience in either quality assurance or quality affairs within a highly regulated industry with experience preparing regulatory submissions.
• Understanding of quality system regulations for medical devise as well as risk management.

Benefit

• Base $100,000 - $130,000 + Super
• Can be a permanent full time or permanent part time role.
• Employee assistance program (wellness and counselling benefits).
• Novated leasing via salary packaging.

To APPLY!
If you meet all the criteria and are available to start immediately, please apply. For any inquiries, please contact Adam at adam.alexander@awxexec.com.au