Medical Device Change Control Expert
Master degree in Science/Engineering or Mechanical Engineering or University level engineering education.
Excellent skills in English language are required.
The successful candidate for this position 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.
An ideal candidate would have a relevant degree in engineering and at least 5 years of experience in a similar area, including:
• Managing medical device/combination product Change Controls
– 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;
• Good communication and conflict solving skills;
• General understanding of pharmaceutical development ;
• General understanding of Human Factors Engineering and Risk management.
– General understanding of manufacturing
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