- Work closely with all staff to manage and maintain ResApp’s QMS to an ISO13485:2016 standard and the FDA’s Quality System Regulation (QSR) requirements
- Write and maintain all controlled documents/procedures and ensure the QMS remains compliant
- Managing the training and internal audit program
- Work closely with internal and external regulatory, clinical and software development teams to integrate their design, development and QA documents into the QMS
- Coordinate management review meetings, including setting times, agendas and review documents
- Experience in ISO9001 or ISO13485 or in a regulated environment is highly desirable
- Understanding of Quality Systems
- Attention to detail and strong project management skills
- Excellent written and verbal communication skills with the ability to work collaboratively
- Life Science, Engineering or Law degree or equivalent medical device experience
- Experience with working in the medical device industry, including knowledge and experience in interpreting regulatory requirements (TGA, FDA and/or CE)
To apply please send a cover email and a copy of your resume to email@example.com.
ResApp Health Limited
ABN 51 094 468 318
Level 12, 100 Creek St, Brisbane, QLD 4000
© 2021 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257, South Korean Patent No. 1020812410000 and Patents Pending. ResApp Health®, the ResApp Health logo and ResAppDx® are registered trademarks of ResApp Health Limited in the United States and other countries. ResAppDx is not available for sale in the United States.