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.
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Medical Device Assessor - APS 5 in Canberra employer: Calleo
Calleo is an exceptional employer that fosters a collaborative and innovative work culture, particularly in its vibrant Canberra, Sydney, and Brisbane offices. Employees benefit from a strong focus on professional development, with ample opportunities for growth in enterprise information architecture and governance, all while working in an Agile environment that values quality and compliance.
