Medical Device Assessor

OnQ Recruitment; Canberra; On-site; AUD 90,000 - 130,000; Full time

Job summary

The Australian Government regulatory authority responsible for the safety, quality and efficacy of therapeutic goods is seeking a biomedical engineer who can interpret legislative guidelines, analyze technical information, and prepare regulatory decisions and notices for clients in Canberra.

Ideal candidates hold a Bachelor's or Master's in Biomedical/Mechanical Engineering, with around a year of experience in the medical device sector and familiarity with regulatory requirements for Class 1–111

Qualifications

• Qualified Biomedical or Mechanical Engineer with a Bachelor's and/or Master's degree.
• 12 months experience in the medical device sector.
• Knowledge of regulatory requirements for Class 1–111 devices.
• Strong communication and technical writing abilities with high attention to detail.

Responsibilities

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

Skills

Communication

Technical writing

Attention to detail

Education

Bachelor's or Master's in Biomedical/Mechanical Engineering

Job description

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.