McArthur are currently seeking applications for the position of APS6 Project and Research Officer. This will be a month role.
As part of this role, your duties and responsibilities will include:
Undertaking the assessment of clinical and regulatory information submitted by medical device manufacturers/sponsors, documenting the results in clearly articulated reports and ensuring recommendations are governed by the application of the Australian Therapeutic Goods regulatory framework
Supporting the application of process improvements for the assessment of clinical evidence by assisting medical advisors in the preparation of reports and drafting work instructions.
Providing timely, quality and accurate advice on issues relating to medical device regulation and interpretation of legislation and guidelines
Contributing to the development and revision of technical and administrative procedures and documentation within the Branch
Managing record keeping in accordance with the regulatory and legislative requirements and whole of- government policy and standards
To be successful in this role, you must meet the following criteria:
An understanding of the Australian regulatory requirements for medical devices, or the ability to quickly develop this understanding
Ability to interpret, draft and review policy and procedural documentation
Ability to prepare clearly articulated assessment reports in a timely manner and in accordance with guidelines and the medical devices legal framework
Ability to apply work knowledge, legislation, policy, procedures and guidelines to situations involving a high level of complexity and sensitivity which require considerable interpretation and analysis
Strong written and verbal communication skills
Technical expertise and experience relevant to the use, assessment, manufacture, design, testing and monitoring of medical devices
Personal capabilities/attributes:
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
Proven ability to produce work requiring little or no revision before finalisation
Maintains a flexible attitude, understanding that priorities may change without notice and able to focus on new priorities in accordance with the strategic direction
Mandatory Qualifications:
Relevant qualifications in science related field of study or biomedical engineering
Desired Qualifications:
Understanding of medical device regulatory frameworks and processes, including knoweldge of the Therapeutic Goods Act 9, the Therapeutic Goods (Medical Devices) Regulations 2 and other legislative instruments and guidelines.
If you feel that you meet the criteria above, please apply using the link provided.
Share this job