Medical Device Assessor

Our client is the Australian Government regulatory authority for the safety, quality and efficacy of therapeutic goods. They evaluate and approve a range of prescription medicines, OTC and complementary medicines, and medical devices before they can be sold in Australia. 

About the Role 
We are looking for a biomedical engineer who has the ability to interpret and apply legislative guidelines and analyze technical information to make informed decisions and prepare high-quality regulatory decisions and notices to clients. 

Key Responsbilities

• regulatory and technical assessment for medical devices including evaluating data, collating relevant expert advice and preparing clear evidence-based assessment outcomes and statements. 
• Managing record keeping with the regulatory requirements
• Providing clear advice and feedback on application assessment requirements and outcomes

About You
To be successful, you will need to be a qualified Biomedical or Mechanical Engineer with a bachelor's and/or master's degree. Ideally 12 months experience working in the medical device sector with some working knowledge of regulatory requirements for a range of devices - Class 1-111. Strong communication skills are essential, with strong technical writing and high attention to detail. This a team orientated environment where you will work closely with a range of stakeholders, and a sense of urgency will be required.