Description
Medical Device Change Control ExpertWe have a contract opportunity of experienced engineer, who will support change control activities within the development and life cycle management of parenteral delivery systems, e.g. drug/device combination products and medical devices.
Required experience:
degree in engineering or any other scientific discipline,
Pre-filled-syringe device development, from early phase activities up to commercialization and production scale-up;
Medical device quality assurance;
DHF compilation, including Design Control process and other applicable regulatory, QA and GMP aspects;
Understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive), ISO13485;
Main Tasks:
Support roll out of new change control process including training of personnel on process and systems
Work with team members across sites to ensure quality documentation meeting all regulatory requirements
Follow up with team members regarding actions to understand and remove roadblocks in completing changes
Review and report KPIs to ensure timelines of change control actions
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.