- Work closely with our QMS consultants to manage ResApp’s QMS per FDA’s Quality System Regulation (QSR) requirements and ISO 13485
- Write and maintain all controlled documents and ensure the QMS remains compliant
- 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 a regulatory environment strongly preferred
- Understanding of Quality Systems
- Attention to detail and strong project management skills
- Excellent written and verbal communication skills with the ability to work collaboratively
- Technical or Life Science degree or equivalent medical device experience
- Experience with medical devices, 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
© 2020 ResApp Health Limited. All rights reserved. US Patent No. 10,098,569, Australian Patent No. 2013239327, Japanese Patent No. 6,435,257 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.