APS5 Medical Device Assessor

Location: Canberra, ACT
Clearance: Ability to obtain and maintain Baseline (existing preferred)
Duration: 6 Months with possible 6-month extension
Hourly Rate: $52-$56 an hour

About The Opportunity:

Our Federal Government client is seeking a detail-oriented and technically capable Medical Device Assessor to support the assessment and regulation of medical devices within Australia's regulatory framework.
This role offers the opportunity to contribute to public health outcomes by reviewing technical documentation, assessing regulatory applications, providing evidence-based advice, and supporting compliance with medical device legislation and regulatory requirements. Working within a collaborative team environment, you will engage with a range of stakeholders while helping maintain the integrity and safety of medical devices supplied to the Australian market.

Key Responsibilities:

- Conduct regulatory and technical assessments of medical device applications and variations.
- Review technical documentation and supporting data to determine compliance with applicable regulatory requirements.
- Prepare evidence-based assessment outcomes, statements of reasons, and regulatory correspondence.
- Provide clear and accurate advice on regulatory requirements, application processes, and assessment outcomes.
- Maintain accurate records in accordance with government policies, procedures, and regulatory requirements.
- Contribute to policy, process improvement, and business enhancement initiatives.
- Build and maintain effective relationships with internal and external stakeholders.
- Support a positive, collaborative, and inclusive team culture.

About You:

You will be a motivated regulatory professional with strong analytical skills and the ability to interpret complex technical information within legislative and policy frameworks.

Skills & Experience:





- Experience assessing technical documentation, data, or compliance-related information.
- Ability to interpret and apply legislation, regulations, policies, and guidelines.
- Strong attention to detail, accuracy, and quality assurance capabilities.
- Excellent written and verbal communication skills.
- Ability to manage competing priorities and meet tight deadlines.
- Strong stakeholder engagement and relationship management skills.
- Ability to work collaboratively within multidisciplinary teams.
- Demonstrated flexibility and adaptability in a changing regulatory environment.
- Sound judgement, organisational skills, and a proactive approach to problem solving.

Highly Regarded:

- Experience in medical device regulation, technical assessment, quality, compliance, or related scientific fields.
- Knowledge of Australian medical device legislation and regulatory requirements.
- Experience evaluating technical documentation and preparing assessment reports.
- Qualifications in health, science, biomedical engineering, life sciences, or a related discipline.

How to Apply:
To apply, click the Apply Now button and send your up-to-date resume, for a confidential discussion call us now on 02 5119 3***.

This advertisement may remain live after the role has closed. Applications submitted after the closing date may be considered for similar vacancies.

If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Our Commitment
We are committed to inclusive and culturally secure recruitment practices and welcome applications from people of all backgrounds, experiences, and career stages. We particularly encourage Aboriginal and Torres Strait Islander peoples to apply.
Additional information

- Location: Canberra, ACT
- Duration: 6 Months with possible 6-month extension
- Clearance: Ability to obtain and maintain Baseline (existing preferred)

📌 Medical Device Assessor (Canberra)
🏢 ONPOINT 365
📍 Canberra