Job details
- Location
- Canberra
- Salary
- Superannuation
- Job Type
- Contract
- Ref
- BBBH35292_1600329081
- Contact
- Joanna Murphy
- Contact email
- Email Joanna
- Contact phone
- +61 2 8877 8718
- Posted
- over 3 years ago
Job details
- Location
- Canberra
- Salary
- Superannuation
- Job Type
- Contract
- Ref
- BBBH35292_1600329081
- Contact
- Joanna Murphy
- Contact email
- Email Joanna
- Contact phone
- +61 2 8877 8718
- Posted
- over 3 years 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 (including IVDs) and OTGs
- 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
3 months ago
Regulatory Affairs
Senior Regulatory Affairs Associate
- Sydney
- Competitive salary package + beneifts
Benefits• Work with a leading Healthcare company with a global presence• Collaborative environment with a supportive team in place• Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medi...
7 days ago
Regulatory Affairs
Senior Regulatory Affairs Associate
- Sydney
- Competitive salary package + beneifts
Benefits• Work with a leading Healthcare company with a global presence• Collaborative environment with a supportive team in place• Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across Medical Devices.<...
5 months ago
Regulatory Affairs
Senior Regulatory Affairs Operations ...
- Sydney
- Great salary and benefits package
Benefits • Work with a leading Healthcare company with a global presence • Collaborative environment with a supportive team in place • Competitive salary package + bonusAbout the CompanyOur client is a leading medical devices company in Australia with a global presence focusing on life-changing technologies with leading products across M...
13 days ago
Quality Assurance
Supplier Quality Engineer
- New South Wales
- Competitive Salary Package
Features:Opportunity to join a reputable medical device and pharmaceutical manufacturer with exposure to FDA, TGA and European Notified Bodies.Collaborative, respectful, and innovative company environment.Competitive Salary Package.Career progression opportunities.Onsite Parking.Benefits Gain exposure in...
2 days ago
Quality Assurance
Quality Control
- Tullamarine
- $36.42 per hour
BenefitsMust have own car and licencePosition is all based on siteSome weekend work is requiredAbout the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunityThe Quality Control will perform sampling ac...
3 days ago
Quality Assurance
Quality Control Analyst
- Dallas
- $35.10 per hour
BenefitsBe part of a supportive and stable working environmentWorking within a global teamMust have unrestricted work rights in AustraliaAbout the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunityTh...