Regulatory Affairs Engineer (Medical Devices) Sydney

THE COMPANY

One of the largest medical device manufacturer in Australia. The company designs, develop, manufacture and deliver innovative Medical device products around the world.

Regulatory Affairs Engineers are responsible for bringing new devices from concept design through development to market release. They drive the devices through all aspects of development to ensure state of the art performance is achieved and patient health is protected. The role is technically challenging, with a heavy emphasis on research and design evaluation skills.

THE ROLE
Preparation of regulatory applications for medical device market clearance (i.e. 510k and CE marking) for orthopaedic implants and their accessories, including joint replacement prostheses, fracture and soft-tissue fixation devices as well as their related surgical instrumentation
Preparation of technical reports and technical files
Development and execution of product verification and validation testing in accordance with recognized national and international standards for medical devices (i.e. ISO, ASTM)
Clinical research of medical devices via literature review and clinical data analysis
Provide regulatory guidance to all company departments, from design development to post market surveillance
Assist in regulatory actions such as incident reporting, customer complaints, device vigilance, device registration, and other pre- and post-market responsibilities as per relevant regulations, including those of the EU, Australia and USA.
THE CANDIDATE

Bachelor's Degree (or higher) in Biomedical or Mechanical Engineering, or similar
Proficiency in word processing and spreadsheet software
Proficiency with technical report writing
Experience with high load mechanical testing equipment valued
Experience within GMP workplace, ISO13485 certification valued
Experience with National and International regulations valued
Has excellent communication and organisational skills.