Quality Assurance and Regulatory Affairs Coordinator (12-month contract)

What's in it for you?
An Australian MedTech success story with a niche portfolio of productsUnique opportunity to work in an organisation operating as distributor, manufacturer and sponsorAn opportunity to get a foot-in-the-door to a great organisation with an exceptional culture
The CompanyOur client is a local success story and truly unique in their space. A 12-month contract opportunity has presented itself in the Regulatory Affairs and Quality Assurance team based out of the head office in Lane Cove West.
The RoleReporting to the QARA Manager, this role will see you primarily working across a range of Quality and Regulatory activities for implants and instruments used in Spinal surgery.
You will be responsible for ensuring compliance with applicable standards (ISO 13485, ISO 9001), TGA Regulations and the internal Quality System requirements. You will assist with documentation record-keeping, internal audits, product registrations, post-market surveillance and will also support the preparation and maintenance of regulatory submissions and QMS documentation.
Responsibilities include:
Support post-market surveillance activities including complaint handling, change control tracking and adverse event monitoringParticipate in internal audits and CAPA trackingContribute to the implementation and reviews of QMS procedures, SOPs and work instructionsProvide support during external audits and inspectionsCompile, review and maintain regulatory documentation and records in line with applicable standards and procedures.Assist in the preparation of technical documentation and submissions to regulatory authorities under supervisionAssist in the organisation and control of quality records including training files, supplier files and equipment calibration recordsAssist with implementation of UDI requirements
About You
Tertiary qualification in life sciences, biomedical engineering, regulatory affairs or related discipline (or working towards one)Completion of relevant training on ISO13485, ISO 9001, TGA Regulatory framework is desirable but not essential2+ years’ QMS management experience preferably in the medical device industry
Although this role has duties across the breadth of the QARA landscape, QMS knowledge in the medical device industry with experience in audits, document control, CAPAs and product complaints is essential.
This is a great opportunity to work with a unique organisation with a fantastic company culture. Get in touch to learn more.