APS 6 Compliance Assessor
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. They provide specialist input in the areas of engineering, biocompatibility, IVDs, and the regulation of medical devices to various internal and external stakeholders. They work directly with specialists in a range of areas including clinical, sterility, and Quality Management Systems (QMS) in relation to the regulation of medical devices. They are also responsible for several major reform and business improvement projects.
Areas of Responsibility
The APS 6 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
Length of Contract
Capabilities, Skills, and Qualifications
- 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, relevant medical device/and or regulatory knowledge or experience or science related field of studies from an Australian tertiary institute or equivalent overseas qualification.
- 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
- Ability to communicate complex regulatory and/or technical matters clearly and concisely to a range of internal and external stakeholders.
- Initiate, establish and maintain strong relationships with a broad range of stakeholders and will exercise consultation skills to effectively liaise with specialists, manufacturers, and Australian sponsors of therapeutic goods
- Maintain technical, professional, and regulatory skills and expertise through continuing professional development and learning, adapt to new fields as needed, and continually identify and contribute to opportunities for organisational capability development and maintenance
- Knowledge of the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002 and other legislative instruments and guidelines would be well regarded
If interested, please apply directly through the links provided. Alternately, contact Kalpana Palaniyappa for more information.
0403 200 666
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