Medical Device Regulatory & QA Officer (APS5)

Indigeco Pty Ltd; Canberra; On-site; AUD 83,000 - 90,000; Full time

Benefits offered by this job

Hourly pay rate of $60 to $65 per hour

Initial 6-month contract with possible

Chance to gain medical device reg. exp

Job summary

Indigeco Pty Ltd is recruiting an APS5 Medical Device Quality & Regulatory Officer for a Commonwealth Government client in Fairbairn, Canberra. The role supports assessment, evaluation and regulatory compliance of medical devices within Australia’s healthcare regulatory environment.

The successful candidate will review applications, interpret requirements, and prepare evidence-based assessment outcomes. Prior medical device regulation experience is valued but related QA/regulatory backgrounds

Qualifications

• Experience in regulatory affairs, quality assurance, compliance, or related regulatory environments.
• Knowledge of medical device regulation and regulatory submissions.
• Ability to interpret technical documentation and apply regulatory requirements.

Responsibilities

• Undertake regulatory and technical assessments of medical device applications to determine compliance.
• Review registrations, amendments, variations, and consent to supply regulatory activities.
• Prepare evidence-based assessment outcomes and statements of reasons.

Skills

Regulatory affairs

Quality assurance

Compliance

Technical assessments

Healthcare

Medical devices

Biomedical engineering

Scientific environments

Job description

Indigeco Pty Ltd is recruiting an APS5 Medical Device Quality & Regulatory Officer for a Commonwealth Government client in Fairbairn, Canberra. The role supports assessment, evaluation and regulatory compliance of medical devices within Australia’s healthcare regulatory environment.

The successful candidate will review applications, interpret requirements, and prepare evidence-based assessment outcomes. Prior medical device regulation experience is valued but related QA/regulatory backgrounds