About the company
The Medical Devices Branches of the TGA evaluate medical devices, including in vitro diagnostic tests, and monitors them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety, and performance.
About the opportunity
This APS 6 role sits within the Devices Post Market Monitoring Section (DPMMS). You will be responsible for undertaking risk assessment and Investigation of adverse event reports associated with the use of medical devices.
- Undertaking assessment of the technical documentation and data, collating expert advice relevant to the assessment, preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations, and exercising delegation where appropriate.
- Undertaking under limited direction, risk assessment and Investigation of adverse event reports associated with the use of medical devices.
- Providing detailed technical engineering/biocompatibility or clinical expertise in the area of medical device technology, including anticipating problems and contributing to issues management
- Coordinating and managing multi-component assessments, investigations and reviews requiring liaison with internal and external professionals
- Implementing a risk management approach to support regulatory decisions
- Dealing with complex issues and managing stakeholders
- Writing statements for publication on the safety and performance of medical devices on TGA's website
- Communicate with relevant stakeholders, including providing advice and feedback on the outcomes of investigations.
Skills and Experience
- Relevant qualifications in science related field of studies or biomedical engineering
- Knowledge of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and other legislative instruments and guidelines
- Experience in investigating adverse events associated with the use of therapeutic goods.
- Ability to interpret, draft and review policy and procedural documentation.
- Technical expertise and experience relevant to the use, assessment, manufacture, design, testing and monitoring of medical devices.
- Strong communication skills including ability to prepare clearly articulated reports and briefs on the subject matter.
- Sound judgment, attention to detail and organisational skills and ability to take responsibility for work, prioritising tasks and producing quality outputs to meet tight deadlines.
How to Apply
Click apply or contact Joanna Murphy, Senior Recruitment Consultant on email@example.com for a confidential discussion.
( SK927795A )
25 days ago
- Canberra, Australian Capital Territory
- AU$57 - AU$60 per hour + super
About the company Medical Devices Surveillance Branch monitors 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.
8 days ago
- South Yarra
- Leading global CRO! Excellent location! Immediate start available!
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 require...
1 day ago
- Attractive hourly rate
Benefits Join a comapny that is a global consumer health leaderWork with well known brands within OTC and consumer healthcareFlexible part time working arrangements About the company A global consumer health leader with a varied product portfolio, across numerous categories. With brands t...
11 days ago
BenefitsDevelop, manage and mentor a team of regulatory affairs professionalsAssist the strategic vision and support business growth from regulatory affairs perspectiveWorking collaboratively with senior leaders across the businessWorking across all medical device areasFlexibility to work from home and in the officeGen...
about 1 month ago
- Southeastern Sydney, New South Wales
About the companyA highly successful bio-pharmaceutical company with an excellent reputation and a strong product pipeline. About the opportunityYou will join a highly motivated and supportive Quality team focusing on product complaints. Your role will be responsible for re...
23 days ago
- New South Wales
About the company A highly successful bio-pharmaceutical company with an excellent reputation and a strong product pipeline. About the opportunity You will join a highly motivated and supportive Quality team focusing on product complaints. Your role will be responsible for registering and triaging complaints, managing p...