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Specifically relating to Go-To-Market Quality, the job holder will.
Support QA Saudi Manager to complete all administrative work related to Quality Management System (QMS) in accordance with ISO 13485:2016 and SFDA requirements.
Coordinate training of employees on quality system requirements Support QA Saudi Manager updating training matrix
Follow up on the tasks assign to him/her in terms of CAPA due date, setting up meeting with concerning team etc.
Ensure all BD Saudi associates have signed Job Descriptions
Support and work with BD local team to complete suppliers documentation requirements.
Specifically relating to Post Market Quality, the job Holder will
Support follow up related to Post-market Quality activities related to complaints reporting and FSCAs execution.
Support reporting Saudi FDA products complaints and execute field safety notice on time and completing required forms and upload required documents in the EMEA SharePoint.
Support to update local and EMEA Center of Excellence tracker and completed on time and in compliance with applicable country regulations and company procedures and upload required documents in the EMEA SharePoint.
Support QA Saudi Manager to response to Vigilance Center of Excellence and the BD Field Action Center of Excellence in managing and responding to local Competent Authority requests.
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Optional Skills
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