Medical Device Regulator (APS5) – 6-Month Contract

Calleo; Canberra; On-site; AUD 70,000 - 100,000; Full time

Job summary

Calleo in Canberra is seeking an APS 5 Medical Device Assessor to join a regulatory team responsible for the assessment and regulation of medical devices. You will evaluate regulatory and technical documentation to ensure compliance with legislative standards.

The role focuses on applications, variations, consent to supply and verification activities, offering meaningful work aimed at patient safety and healthcare outcomes. Australian Citizens only per role.

Qualifications

• Ability to interpret and apply legislative and regulatory frameworks, policies, guidelines, and technical information to make informed decisions.
• Strong analytical and problem-solving skills with the ability to assess complex technical documentation.
• High level of attention to detail, accuracy, and consistency.
• Excellent written and verbal communication skills, with the ability to engage effectively with a range of stakeholders.
• Ability to adapt to changing regulatory requirements, policies, and business priorities.

Responsibilities

• Conduct regulatory and technical assessments of medical device applications, including evaluation of technical documentation and supporting data.
• Prepare clear, evidence-based assessment reports, decisions, statements of reasons, and regulatory correspondence.
• Interpret and apply relevant legislation, regulatory frameworks, policies, guidelines, and procedures.
• Manage record keeping activities in accordance with regulatory obligations and government standards.
• Contribute to policy, process improvement, and business enhancement initiatives relating to medical devices.

Skills

Regulatory frameworks

Regulatory assessment

Analytical skills

Attention to detail

Written communication

Stakeholder engagement

Adaptability

Job description

Calleo in Canberra is seeking an APS 5 Medical Device Assessor to join a regulatory team responsible for the assessment and regulation of medical devices. You will evaluate regulatory and technical documentation to ensure compliance with legislative standards.

The role focuses on applications, variations, consent to supply and verification activities, offering meaningful work aimed at patient safety and healthcare outcomes. Australian Citizens only per role.