Aps Level 5 - Melbourne, Australia - National Health Funding Body
Description
Job Reference Number 23-MDPQDIV-17220
Classification APS Level 5
Job Title Review Coordinator
Division Medical Devices and Product Quality Division
Branch Medical Devices Surveillance Branch
Section Device Post Market Reforms and Reviews Section
Applications open date Wednesday, 12 April 2023
Applications closing date Wednesday, 26 April 2023 at 1130pm AEST
Location Melbourne VIC, Fairbairn ACT, Parramatta NSW
Status Ongoing
Employment type Full-time
Salary Range $81,372 - $88,000
Contact Officer Name:
Amanda Craig
Phone:
Eligibility
- To be eligible for employment with the Department of Health and Aged Care
- An applicant's suitability for employment with Health will also be assessed through a
variety of pre-employment check processes, such as:
- Satisfactory completion of a criminal history check, and where relevant a
- Completion of a medical declaration and preemployment medical (where
- Providing evidence of qualifications.
Division Responsibilities
MDPQD ensures Australian and international therapeutic goods manufacturers and
products meet the highest standards for quality, safety, and performance. MDPQD regulates
the quality of therapeutic products for the Australian community by:
- assessing medical devices, including in vitro diagnostic tests.
to meet appropriate levels of quality, safety, and performance; and
- auditing and certifying manufacturers against manufacturing standards so the
products they produce meet appropriate quality, safety, and performance standards.
We undertake monitoring, investigation and review activities for post market regulatory
monitoring and reforms and remain abreast of emerging technology and adoption in
medical devices and monitoring against regulatory frameworks. We monitor medical
devices, including in vitro diagnostic tests (IVDs) and other therapeutic goods (OTGs),
throughout their lifecycle to ensure they continue to meet appropriate levels of quality,
safety, and performance.
Branch Responsibilities
The Medical Devices Surveillance Branch contributes to the vision of the Health Products
Regulation Group (HPRG) and wider Department 'Better health and wellbeing for all
Australians through monitoring medical devices, including in vitro diagnostic tests (IVDs) and
other therapeutic goods (OTGs), throughout their lifecycle to ensure they continue to meet
an appropriate level of quality, safety, and performance'. The Branch undertakes complex
monitoring, analysis investigation and review activities for post market regulatory
monitoring and reforms and keeps abreast of emerging technology and adoption in medical
devices and monitoring against the necessary regulatory framework.
Section Responsibilities
The Device Post Market Reforms and Reviews Section (DPMRRS) within the Medical Devices
Surveillance Branch is responsible complex monitoring, analysis, and review activities for
post market regulatory programs for medical devices. The section is also responsible for the
development and implementation of post-market reforms for medical device regulation and
business processes.***
Key Responsibilities
The APS5 Review Coordinator is responsible for
- co-ordinating communications and submissions in relation to post-market
surveillance activities of the TGA.***- providing secretariat support for working groups***- Input of signals for potential post-market reviews of medical devices into the review
database.
- Collating and coordinating responses to requests under the Freedom of Information
- Drafting and reviewing operating procedures and guidance documents.
- Performing general administrative duties as required.
- Requesting information and samples from sponsors and manufacturers during the
- Participation in the implementation of the TGA's reform work.
- Assistance under supervision in preparation of ministerial briefs, other parliamentary
- Represent the TGA at various internal and external meetings.
Key Capabilities
- Sound judgment, attention to detail, organisational skills and ability to take
deadlines.
- Maintains a flexible attitude, understanding that priorities may change without
priorities, practices, and methodologies to deliver quality outcomes.
Minimum Requirements
RecruitAbility is a scheme which aims to attract and develop applicants with disability and
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