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SalaryA regulatory agency of the Australian Government that carry out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard.
The APS 6 Medical Device Assessor is responsible for undertaking regulatory and technical assessment of applications for inclusion of Medical Devices and variations to existing ARTG entries in the Australian Register of Therapeutic Goods (ARTG), through the evaluation of technical documentation and data.
Key duties
- Undertaking under limited direction, regulatory and technical assessment of the applications for Medical Devices, including evaluation of the technical documentation and data, collating expert advice relevant to the assessment, and preparing a clear statement of reasons based on the investigation findings and knowledge of the regulations
- Providing timely, quality and accurate advice issues relating to Medical Device regulation.
- Communicating with relevant stakeholders, including providing advice and feedback on the outcomes of application assessment.
- Dealing with complex issues and managing stakeholders under limited direction.
- 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.
- Contributing to a positive, collaborative and diverse workplace culture in line with the APS Code of Conduct and iCare Values.
- A high degree of experience, knowledge or familiarity with Medical Devices and regulatory requirements in relation to their inclusion and variations in Australia, the European Union and other regions.
- Demonstrated ability to interpret and apply legislative and regulatory frameworks, guidelines, and policies and analyse technical information to make informed decisions.
- Demonstrated ability to prepare high quality regulatory decision letters, notices and communications.
- Demonstrated ability to adapt to changes in regulations, guidelines and policies relating to Medical Devices, and be able to quickly learn and implement new regulatory requirements.
- High level of attention to detail, accuracy, and consistency in performing regulatory tasks.
- Strong communication skills, including the ability to communicate effectively with multiple stakeholders.
- Ability to meet multiple deadlines with conflicting priorities.
- Ability to work collaboratively in teams.
- 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
- Relevant higher education qualification in health or science related field of studies or biomedical engineering
Click APPLY or contact Marisa Conlon, Senior Consultant, Talent Acquisition at marisa@fprs.com.au for further information on the role.
Please submit applications in Word format only by 10am, 28th February 2024.
FIRST PEOPLE Recruitment Solutions is a 100% Indigenous owned agency providing contingent contracts, fixed term contracts and permanent recruitment solutions to Government and Corporate Australia.
Our Head Office is based in Canberra with a national reach to all the states and territories, regional and remote areas of Australia.
FIRST PEOPLE Recruitment Solutions encourage applications from Indigenous Australians and Non-Indigenous Australians together with people from culturally diverse backgrounds.
FIRST PEOPLE Recruitment Solutions acknowledges the traditional owners of country throughout Australia and recognizes their continuing connection to land, waters and community. We pay our respect to them and their cultures; and to elders both past, present and emerging.
