Medical Device Assessor - APS 5

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

Medical Device Assessor - APS 5

6 months labour hire contract with scope for extension

Meaningful work that impacts patient safety and healthcare outcomes

Fairburn ACT location

Overview

An exciting opportunity is available for an APS 5 Medical Device Assessor to join a high-performing regulatory team responsible for the assessment and regulation of medical devices. This role focuses on undertaking regulatory and technical assessments of medical device applications, variations to existing registrations, consent to supply applications, and verification activities.

Working within a collaborative environment, you will evaluate technical documentation and data, interpret regulatory requirements, and contribute to ensuring medical devices meet legislative and regulatory standards. This position is suited to a detail-oriented professional with strong analytical skills and an interest in medical device regulation and compliance.

Duties and 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 and Experience

• 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.

Desirable Skills

• Experience undertaking regulatory and technical assessments of medical devices through the evaluation of technical documentation and supporting evidence.
• Familiarity with Australian and international medical device regulatory frameworks, including exposure to European Union regulatory requirements.
• Background in medical devices, biomedical sciences, engineering, healthcare, life sciences, quality assurance, or a related discipline.

Due to the nature of this role, this job is open to Australian Citizens only.

Calleo is an equal opportunity employer, and we encourage applications from all people including Aboriginal and Torres Strait Islander peoples.