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Regulatory Affairs Engineer (Medical Devices) Sydney

konnecting - Sydney, NSW

Source: uWorkin



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.


  • 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.


  • 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.

How to Apply
If you think you are qualified and interested, please email your updated resume to [email protected], quoting reference #3186217

About Konnecting

Konnecting is an Australian Skilled Migration & Recruitment Consultancy that sources candidates for niche roles. We are also a registered migration agency that processes Australian employer sponsored 482 visas. For more positions offering visa sponsorship, or for other Australian visa information, please visit www.konnecting.com