Quality Assurance and Regulatory Affairs Associate

**Full Time - 18 months contract**

We are seeking a highly motivated Quality Assurance and Regulatory affairs (QRA) personnel to assist the development and management of a Quality Management System (QMS) in-line with applicable global regulatory requirements and quality standards. The QRA Associate will work closely with the QRA team, Project Manager, and the Engineering team in the early phase of development and implementation of quality policies and procedures to facilitate relevant certifications and regulatory compliance at Chris O’Brien Lifehouse.

**About the Role**

The primary function of the QRA Associate role is to assist with the development, implementation, operation and ongoing maintenance of a new QMS at Chris O’Brien Lifehouse point of care manufacturing facility. This involves drafting of procedures, supporting QRA processes, and the implementation, monitoring and maintenance of these procedures.

The QA&RA Associate will also assist and coordinate Post Market Vigilance activities related to sponsors obligations under the Therapeutics Goods Act 1989 and Australian Regulatory Guidelines for Medical Devices (ARGMD).

Where necessary, the QA&RA Associate will also provide support to other projects and activities where priority is required, which may involve utilizing analytical and problem-solving skills.

**About You**
- Strong technical writing capabilities
- Attention to detail and accountability
- Excellent communication skills: fluent English (oral & written) required
- Strong decision making and problem-solving skills
- Strong communication skills
- Excellent Microsoft software skills
- Ability to adapt and collaborate with various stakeholders
- Keen to learn and enjoy working as part of a team

**Main Tasks**
- To assist with drafting of documentation and implementation of QMS and QA &RA process towards meeting ISO13485:2016 standards and regulatory requirements.
- To assist with updating, maintaining and improving QMS process and documentation, once QMS is implemented.
- To assist with communications of quality related updates, developing of training programs and conducting training.
- To assist with maintaining compliance to the established QMS for change controls, CAPA, deviations, complaints, internal and external audits, and associated documentation working closely with multiple stakeholders.
- To assist with the preparation of documentation for technical files and other documentation for Medical Devices and Biologics listings/registrations.
- Review of incoming inspection records provided by manufacturing.
- To participate in product quality review, CAPA and investigation process to resolve production issues to ensure that all compliance parameters meet expected outcome at each stage of product lifecycle.
- To assist with patient risk management process.
- To assist in ensuring all applicable standards are met in relation to regulatory, internal stakeholder and customer requirements.
- To assist and coordinate Post Market Vigilance activities.
- To provide an administrative support for Management Review meetings or QRA meetings.
- To support the QRA team and Project Manager with day-to-day duties, as required.

**Key Selection Criteria**:

- Tertiary education in a technical discipline (e.g Science, Engineering, Biomedical or related).
- Minimum 1-year Regulatory Affairs experience.
- Demonstrated understanding of principles of quality assurance and control.
- Experience supporting quality management in a medical device field is desirable.
- Attention to detail and excellent communication skills (verbal and written).
- The drive and determination for continuous improvement.
- Well-developed organizational skills and time management skills with the capacity to meet deadlines and effectively balance competing demands to meet set goals.
- At Chris O’Brien Lifehouse, we are committed to providing a working environment where each individual is valued, respected, and supported to progress. Our priority is to ensure culture, policies, and processes are truly inclusive and that no one is disadvantaged on the basis of their Aboriginal and Torres Strait Islander identity, gender, culture, disability, LGBTIQA+ identities, family and caring responsibilities, age, or religion. We encourage everyone who meets the selection criteria and shares Chris O'Brien Lifehouse values to apply._