Job details

Location
Canberra
Salary
Superannuation
Job Type
Contract
Ref
BBBH35292_1603769769
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61288778718
Posted
about 1 month ago

Job details

Location
Canberra
Salary
Superannuation
Job Type
Contract
Ref
BBBH35292_1603769769
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61288778718
Posted
about 1 month ago

About the company

The Medical Devices Authorisation Branch of the TGA evaluates medical devices, including in vitro diagnostic medical devices (IVDs), and monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance

About the opportunity

The Devices Applications Section (DAS) within the Medical Devices Authorisation Branch is responsible for pre-market assessment of applications for inclusion of medical devices (IVD and non-IVD) and applications for listing and registration of other therapeutic goods (OTG) in the ARTG.

Duties

  • Undertake desk top regulatory and technical assessments of pre-market inclusion applications for medical devices (including IVDs) and OTGs in the ARTG, interpret and apply legislation, regulatory guidelines, international standards and best-practice, collating expert advice relevant to the assessment, preparing clear statements of reason based on the investigation findings, matters of fact, and knowledge of the regulations, and exercising delegation where appropriate.

  • Provide timely technical/professional advice to internal and external stakeholders.

  • Be responsible for record keeping and record management of official decisions and actions in accordance with the Department of Health's record management protocols.

  • Participate in providing quality improvement in regulatory processes and reform in key areas, according to government priorities.

  • Positively contribute to representing the TGA at various internal and external meetings as necessary to fulfil the TGA's functions as the national regulator of the therapeutic goods as required.

  • Contribute to broader organisational objectives by undertaking other tasks as required.

  • Contribute to a positive, collaborative, and diverse workplace culture in line with APS Code of Conduct and Care Values.

Skills and Experience

  • Relevant Qualifications in medical science, or health related field of studies.

  • Experience in regulatory and technical assessments and reporting through evaluation of technical documentation and data in the field of medical devices will be highly regarded.

  • Ability to maintain knowledge of relevant legislative and reporting requirements, Australian and International standards, quality assurance procedures and best practice models

  • Ability to apply comprehensive work knowledge, precedent and established legislation, policy, procedures, and guidelines to situations involving a high level of complexity and sensitivity which require considerable interpretation and analysis

  • Ability to provide significant and detailed advice on regulatory issues related to medical devices and/or diinfectants

  • Ability to interpret, draft and review policy and procedural documentation

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on +61 2 8877 8718 for a confidential discussion.

( SK927795A )

Similar jobs

8 days ago

Quality Assurance

Senior Quality Manager - Medical Devices

  • New South Wales
  • Superannuation

About the companyA rapidly growing organisation and one of Australia's leading suppliers of sterile and non-sterile medical consumables. About the opportunityThe Senior Quality Manager role is a newly created position and reports into the Head of Quality. You will support and guide a team of quality...

about 1 month ago

Quality Assurance

Senior Quality Manager - Medical Devices

  • Western Sydney, New South Wales
  • Superannuation

About the companyA rapidly growing organisation and one of Australia's leading suppliers of sterile and non-sterile medical consumables. About the opportunityThe Senior Quality Manager role is a newly created position and reports into the Head of Quality. You will support and giude a team of quality...

about 23 hours ago

Regulatory Affairs

Regulatory Affairs Associate - 12 Mon...

  • New South Wales
  • Negotiable

BenefitsWork in a friendly and supportive environmentA global organisationFlexible working arrangements About the companyA leading medical device company with a global reach. About the opportunityOn a 12-month contract you will re...

22 days ago

Regulatory Affairs

Regulatory Affairs Associate

  • Victoria
  • Negotiable

About the companyThis global CRO are committed to developing groundbreaking devices and new pharmaceutical products. About the opportunityIn this role, you will responsible for ensuring the timely submission of regulatory documents related to clinical trial activity Duties Perform...