Careers

Quality and Regulatory Affairs Manager

Melbourne based

Market leading technology organisation

Flexible hours

Start part-time and possibility of full-time

dorsaVi is a publicly listed company who specialise in developing innovative wearable sensor technology used to analyse movement and muscle activation in the workplace and clinical settings. dorsaVi wearable technology enables, for the first time, many aspects of detailed human movement and position to be accurately captured, quantified and assessed outside a biomechanics lab, in real-time.

The Quality and Regulatory Affairs Manager will be responsible for the maintenance of the current quality management system (ISO 13485) certifications, systems, and practices. They will act as the management representative and support the organisation in preparing for and coordinating accreditation audits and risk based internal audits.

They will provide technical expertise to the leadership team as well as developing reporting to inform product and process decision making within the organisation, maintain the training matrix, manage change requests and oversee and support CAPA controls. The successful applicant will have a strong knowledge of regulatory standards, act as an internal resource in reference to regulatory matters and drive the preparation and submission of regulatory applications for dorsaVi products and services. A strong knowledge of driving a risk framework is required.

 

Selection Criteria –

  • Strong knowledge of Quality systems and standards – ISO 13485, FDA CFR 21 Part 820 and ISO 14971
  • Lead Auditor qualification
  • Experience driving a quality system within an organisation
  • CAPA Management experience
  • Knowledge of TGA and FDA standards and principals
  • Experience working with a medical device or technology based product preferred
  • A proven record in developing audit plans and schedules and rolling them out
  • Ability to influence others and implement practices and programs
  • Experience in internal auditing and coordinating accreditation process
  • Knowledge of records maintenance processes as well as report preparation
  • Strong communication and listening skills with the ability to share knowledge
  • A strong knowledge of the Microsoft Suite of packages

 

We are looking for an experienced candidate who is looking to work either part-time and may consider full-time work in the future.

We are delighted that our team engagement survey results recently saw a 100% satisfaction score across the organisation. So to apply and join our growing global team please forward both a cover letter responding to the above criteria, and a resume to hr@dorsavi.comor follow the online application process. For additional information, you can email Jenny Mate (Head of People and Culture) at hr@dorsavi.com. Applications close     .

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