Mythili Balu
Senior Product Manager at 3Analytics- Claim this Profile
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Bio
Experience
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3Analytics
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United States
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Software Development
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1 - 100 Employee
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Senior Product Manager
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Aug 2023 - Present
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SME Lead - Medical Devices
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Apr 2023 - Jul 2023
IMDRF codes, Post Marketing Surveillance - Medical Devices
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HCLTech
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India
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IT Services and IT Consulting
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700 & Above Employee
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Lead Engineer
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Mar 2021 - Mar 2023
Worked on meeting the metrics, CAPA Process, quality check of end to end complaints, Internal audit process and supported in ISO audit. Worked on meeting the metrics, CAPA Process, quality check of end to end complaints, Internal audit process and supported in ISO audit.
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Tata Consultancy Services
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India
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IT Services and IT Consulting
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700 & Above Employee
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System Engineer
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Jan 2017 - Feb 2021
Worked on end to end processing of Medical Device Complaint involving malfunction and adverse events. - Intake of complaints around the Globe - Good Faith effort - Investigation - US FDA Reportability Determination - MDR Submission (Initial & Supplemental reports) - Closure of Complaint Worked on end to end processing of Medical Device Complaint involving malfunction and adverse events. - Intake of complaints around the Globe - Good Faith effort - Investigation - US FDA Reportability Determination - MDR Submission (Initial & Supplemental reports) - Closure of Complaint
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Education
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Rajalakshmi Engineering College
Bachelor of Engineering - BE, Biomedical Engineering