Aps6 Medical Device Assessor

This Division is part of the Health Products Regulation Group.
They monitor and tests the quality of medicines and Medical Devices approved for supply in Australia and works to ensure Australian and international therapeutic goods manufacturers meet specified standards.
The Opportunity
This is an opportunity for you to take the next step in your career if you have a scientific background, understand industry standards, and can implement policy in line with legislation.
If you have been looking to break into the APS with an academic background this is the role for you. You will be working alongside senior executives, liaising with internal and external stakeholders.
This role will give you the platform to share your knowledge and expertise to contribute to the broader division’s strategic goals.
The Role
The Branch approves Medical Devices, ensuring compliance with standards.
The APS6 Medical Device Assessor assesses applications for device inclusion and variations, conducting regulatory and technical evaluations, providing advice, and managing stakeholder communication.
Responsibilities also include record-keeping, policy contribution, and fostering a positive workplace culture.

• Undertakes regulatory and technical assessment of Medical Device applications for ARTG inclusion and variations.
• Evaluates technical documentation, provides expert advice, and prepares clear statements of reasons.
• Offers timely and accurate advice on Medical Device regulation issues.
• Manages complex issues and stakeholders under limited direction.
• Contributes to a positive workplace culture, complying with regulatory requirements, and provides input for policy development.

The Ideal Person
The ideal candidate must possess a clinical background in fields like clinical nursing, engineering, medical science, toxicology, or material science.
They should have technical expertise in the use, assessment, design, testing, and monitoring of Medical Devices. Key qualifications include the ability to interpret, draft, and review policy documents, along with maintaining knowledge of legislative requirements and quality assurance models.
Demonstrated experience in implementing legislation, policy, and guidelines in complex and sensitive situations is crucial.
Strong communication skills are necessary for articulating reports and briefs to diverse audiences.
Salary / Rate

• $60-$70 p/h + super
• 6-month contract with extension possibilities

How to Apply
To apply online, please click on the appropriate link.
You must be an Australian citizen willing to undergo a police check to be successful for this role
Alternatively, for a confidential discussion, please contact Hannah Hawkins on 02 6108 4878 quoting ref no. 19111
HorizonOne is committed to building a diverse and inclusive workforce and we encourage applications from people of all cultures, capabilities and backgrounds