Biomedical Engineer - Regulatory Medical Device Assessor

On Q 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

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