- An Australian MedTech success story with a niche portfolio of products
- Unique opportunity to work in an organisation operating as distributor, manufacturer and sponsor
- An opportunity to get a foot-in-the-door to a great organisation with an exceptional culture
The Company
Our 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 Role
Reporting 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 monitoring
- Participate in internal audits and CAPA tracking
- Contribute to the implementation and reviews of QMS procedures, SOPs and work instructions
- Provide support during external audits and inspections
- Compile, 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 supervision
- Assist in the organisation and control of quality records including training files, supplier files and equipment calibration records
- Assist 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 essential
- 2+ 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.
Quality Assurance and Regulatory Affairs Coordinator (12-month contract) in Sydney employer: OneMD
Join a leading orthopaedic manufacturer in Brisbane that prioritises clinical excellence and innovation, offering a dynamic work environment where your contributions directly impact patient outcomes. With a strong focus on collaboration and professional growth, you'll have the opportunity to build lasting relationships with top surgeons while enjoying a competitive salary package, performance incentives, and career development opportunities. This is an ideal workplace for ambitious sales professionals who value quality and meaningful partnerships over transactional selling.
