Jennifer Bailey
Project Manager, Regulatory Affairs and Quality at Elekta
Based in Cypress, United States
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Seniority
Manager
Department
Manufacturing & Production
Location
Cypress
Industry
Medical Equipment Manufacturing
Company size
4.9K
Contact information
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j•••••••@elekta.com
Phone
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Background
About Jennifer Bailey
Quality and Regulatory for 10 years with an additional 3 years of experience in Software Support in a competitive Medical Device company. Extensive background in Project Management. Responsible for ensuring compliance with FDA, ISO 9001, 13485, MDSAP, and MDR by maintaining our Audit Program, CAPA Program, Risk Management, Document Control and Training Requirements. Skills in supervising processes and employees in Quality Assurance. Responsible for leading process improvement within the Regulatory Affairs organization. Deputy Management Representative for 5+ years. This has included being the external audit escort and representative of the company, including responses to regulatory agencies. Proficient in DocCompliance, M-Files, MasterControl, SalesForce, Excel, Visio, Publisher and Word.
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