Number of Positions – 1
Start Date – ASAP
Location – Canberra
Length of Contract – 12 months
Hours – Full-time
Our client is responsible for pre-market conformity assessment certification of manufacturers of medical devices and In-Vitro Diagnostics (IVDs). This includes conducting technical and regulatory assessment of medical devices, especially those that are high risk. The section provides specialist input in the areas of engineering, bio-compatibility, IVDs, and the regulation of medical devices to various internal and external stakeholders including at major fora. The section works directly with specialists in a range of areas including clinical, sterility, and Quality Management Systems (QMS) in relation to the regulation of medical devices. The section is also responsible for several major reform and business improvement projects.
The Compliance Assessor is responsible for undertaking complex regulatory processes and technical assessment of applications for medical devices through evaluation of technical documentation and data; documenting the results in clearly articulated technical reports. Compliance assessors also support the section through contributing to business improvement or reform projects and through supporting various internal and external stakeholder engagement activities.
- Coordinating and managing multi-component applications requiring liaison with internal and external professionals.
- Contributing to the processing and assessment of conformity assessment applications and management of work queues; manage high volume processing activity within tight timeframes and quality standards.
- Preparing reports that are well-reasoned, clear, concise and critically reviewed for decision in a timely manner.
- Research, interpret and apply legislation, regulatory guidelines, international standards and best-practice when undertaking medical device evaluations.
- Providing timely, professional and accurate advice on issues relating to medical devices regulation, interpretation of legislation, guidelines, best-practice, emerging technologies, and fields of expertise.
- Managing and evaluation of high risk medical devices conformity assessment applications using good judgement and expertise, and ensuring these recommendations are governed by the application of the Australian therapeutic goods regulatory framework and state of the art technical standards or other best-practice guidelines
- Support reporting and analytics of regulatory processes to inform section management and the executive.
- Support the design, development and implementation of new business processes including supporting an adaptable approach to change
- Contribute expertise to branch communications and stakeholder engagement activities
- Manage record keeping in accordance with the regulatory and legislative requirements and whole of- government policy and standards
- Contribute to a positive, collaborative and diverse workplace culture.
- Other duties as assigned from time to time
- Ability to interpret, draft and review policy and procedural documentation
- 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
Relevant qualifications in biomedical engineering or science related field of studies from an Australian tertiary institute or equivalent overseas qualification.
If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
0403 200 666
Follow Calleo on LinkedIn and visit our website to keep up to date on all our current job vacancies: