ECO Officer

Responsibilities:
1) ECR/ECO initiation:
a. Initiation of the ECR process with the ECR/ECO owner
b. Reviewing/ensuring clear & well-defined documents, mainly focusing on changes definitions, changes implications & the requirements.
c. ECR approval; coordination with owner, approvers & QA.
2) ECR/ECO management:
a. Scheduling ECR/ECO meetings, including agenda building.
b. Follow-up & monitoring of required activities execution
c. KPI’s & reports: building & monitoring to sustain effective process
3) ECO approval:
a. Finalizing & approval of the ECO, including all required meeting & activities with QA, RA and other relevant functions.
4) Documentation writing & support: supporting the ECR/ECO owners with writing, reviewing & corrections; implementation GDP (Good Documentation Practices) in the ECR/ECO process.
5) Excellence & improvements: continuously implement improvements to gain excellence and efficient process
Education and relevant Experience:
1) B.A./B.Sc. degree – Mandatory
2) Industrial engineering or related Medical devices areas – an advantage
3) 3-5 years of experience in projects/tasks management in a similar position
4) Working in complex/Global organization – mandatory
5) English – full proficiency