aps6 post market investigator in Canberra

posted
contact
taylor dudley, randstad
job type
permanent

job details

posted
location
canberra, australian capital territory
specialism
government & defence
job type
permanent
working hours
Full-Time
reference number
90M0434158_1608710863
contact
taylor dudley, randstad
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job description

Randstad is exclusively working with the Theraputic Goods Administration to support their recruitment processes in the Medical Devices Branch. Please follow the link at the bottom of the page to lodge your application directly with the Department.

About the Health Products Regulation Group

Regulation that protects and enhances the health and safety of the community is a major component of a high quality health system. The Health Products Regulation Group supports timely access to products that will help achieve better health and wellbeing, whilst checking that these products do not themselves put Australians' health and safety at risk. We achieve this through regulation of therapeutic goods and certain controlled drugs and drug substances. This applies to all such goods exported, imported, supplied and manufactured in Australia.

The Opportunity

Post Market investigator APS6 – (Ongoing, Non-ongoing, Fulltime, Part-Time)

The Post Market Investigator is responsible for coordinating investigations and undertaking assessments of submissions in relation to the post-market investigations of medical devices.

Devices Post Market Monitoring Section

This Sections undertakes risk assessments of all reports entered into the Incident Report Investigation Scheme (IRIS) database and conducts in-depth investigations if necessary. The section also reviews information provided on an annual basis by sponsors of medical devices that are Active Implantable Medical Devices (AIMD), Class III and implantable Class IIb; and information related to the close-out of recall actions.

Skills Required

Duties within this position are not limited to, but may include:

  • 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 signals associated with medical devices
  • Providing detailed technical engineering/biocompatibility or clinical expertise in the area of medical device technology, including participating 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
  • Providing timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines in a particular area of expertise and knowledge
  • Managing record keeping in accordance with the regulatory requirements and whole of government policy and standards
  • Providing inputs and advice to the policy development and business improvement related to medical devices when required and where appropriate
  • Representing the TGA at education seminars, conferences and workshops
  • Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.

Please note, this vacancy will be open for applications until Monday 11 January 2021 and interviews will be held in early 2021.

We seek people with a wide variety of skills and competencies, and look for applicants who demonstrate they will strive to support the behaviours we seek to foster in our workforce. We are an inclusive employer and promote, value and support diversity among our employees with the aim of ensuring our workforce reflects, respects and benefits from diverse communities including Indigenous Australians, people from culturally and linguistically diverse backgrounds, LGBTQI+ and people with disability.

Eligibility

To be eligible for employment with the Department of Health applicants must be an Australian citizen at the time an offer of employment is made.

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 an Australian Federal Police criminal history check, and where relevant a Working with Children and Vulnerable People Check.
  • Completion of a medical declaration and pre-employment medical (where required).
  • For this role applicants must be able to obtain and maintain a Baseline security clearance, or hold a current security clearance of an appropriate level.

For further enquiries about these vacancies please contact:

Taylor Dudley - Scribing and Campaign Manager, Federal Government

02 6132 3816 | Taylor.Dudley@randstad.com.au

Please submit your application directly with the Department. Randstad are not accepting applications directly but are the main point of contact for any questions or queries with regards to this process. Copy and paste the below link into your browser to apply!

shorturl.at/kCDGL

At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.

skills

The APS Level 6 Post Market Investigator is responsible for co-ordinating reviews and undertaking assessments of submissions in relation to the post-market reviews of medical devices

qualification

relevant qualifications, please download job pack for specific information

educational requirements

Bachelor Degree