Sushmitha Sampath Email & Phone Number
@medtronic.com
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Who is Sushmitha Sampath? Overview
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Sushmitha Sampath is listed as Senior Regulatory Affairs Specialist at Nevro at Nevro, a company with 1135 employees, based in Los Angeles Metropolitan Area, United States, United States. AeroLeads shows a work email signal at medtronic.com and a matched LinkedIn profile for Sushmitha Sampath.
Sushmitha Sampath previously worked as Senior Regulatory Affairs Specialist at Nevro and Member at Regulatory Affairs Professionals Society (Raps). Sushmitha Sampath holds Master'S Degree, Bioengineering And Biomedical Engineering from University Of Southern California.
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About Sushmitha Sampath
Highly motivated and experienced Regulatory Affairs and Quality Assurance professional with a demonstrated experience in Regulatory Submissions and Risk Management for medical devices and pharmaceutical industries. Growing interest in Digital Health Technology (SaMD) and Companion Diagnostics.Email id: sushmitha05.sampath@gmail.comI have authored 510(K) for class 2 ophthalmic devices for the global medical device industry. I am also a CITI certified GCP auditor and have audited Pre-diabetic clinical trial. Currently leading a team of 4 members for an IND submission. My current research includes proposing a new methodology for risk management for class 3 Continuous Glucose Monitors to be used in medical devices industry that can be useful in manufacturing as well as from a business standpoint. I have thorough knowledge on Pre-Cert program and its working model for Digital Health Technology.Core Competencies:- Regulatory Submissions (FDA, EU and China)- Regulatory Intelligence- Development of Quality Assurance Plan - Risk Management- Clinical Trials Auditing- Writing SOP- CAPAPlease email me at sushmitha05.sampath@gmail.com for opportunities in Regulatory Affairs and Quality Assurance
Listed skills include Microsoft Excel, Microsoft Powerpoint, Microsoft Office, Leadership, and 38 others.
Sushmitha Sampath's current company
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Sushmitha Sampath work experience
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Senior Regulatory Affairs Specialist
Current
Member
Current
Senior Regulatory Affairs Specialist
Regulatory Affairs Specialist- Europe (Eu Mdr)
Ra & Qa Consultant/ Gcp Auditor At The Usc International Regulatory Consulting Center
Responsibilities Include:o Regulatory Strategy: Developed regulatory strategies for medical devices to be marketed in EU, US and Chinao 510(K) Submission: Authored 510(k) for international clients and managed its submission for Class II ophthalmic medical devices to the FDA by determining predicate device through analyzing FDA 510(k) FOIA package and.
Process Improvement Consultant
o Designed a clinical workflow with implementation of Integrated Practice Unit framework for diabetic specialty clinicso Evaluated its outcome and assessed its impact on value-based care for patients using data analysis
Member
- Designed a prototype for non-invasive, inexpensive, Bluetooth compatible Urea Monitor using Arduino and hardware consisted of thermostat, oscillator, peristaltic pumps and valves using principle of Spectrophotometry.
- Contributed in designing the peristaltic pump and its implementation using Arduino.
- This project was presented in a National level project display competition and won the second place among 60 participants.
- As a member of IEEE-EMB Society, I conducted various intra-college and inter-college technical events.
Biomedical Engineer -Trainee
- Gained hands-on experience on instruments used in Operating Environment which includes Ventilator, Intra-Aortic Balloon Pump and Heart-Lung machine and Vascular devices
- Learnt how to troubleshoot different medical devices.
- Familiarity with Radiological devices and Cardiac devices.
Summer Research Assistant
- Worked on building a prototype of a closed loop control system for controlling Mean Arterial Pressure during surgeries by regulating the anesthetic agents.
- Implemented the hardware design in LabView.
- Contributed to the software implementation for the controller using MATLAB - PID Controller and Fuzzy Logic.
- Gained knowledge about Fuzzy logic toolbox and State space model.
Sushmitha Sampath education
Master'S Degree, Bioengineering And Biomedical Engineering
Bachelor Of Engineering (B.E.), Biomedical/Medical Engineering
Frequently asked questions about Sushmitha Sampath
Quick answers generated from the profile data available on this page.
What company does Sushmitha Sampath work for?
Sushmitha Sampath works for Nevro.
What is Sushmitha Sampath's role at Nevro?
Sushmitha Sampath is listed as Senior Regulatory Affairs Specialist at Nevro at Nevro.
What is Sushmitha Sampath's email address?
AeroLeads has found 1 work email signal at @medtronic.com for Sushmitha Sampath at Nevro.
Where is Sushmitha Sampath based?
Sushmitha Sampath is based in Los Angeles Metropolitan Area, United States, United States while working with Nevro.
What companies has Sushmitha Sampath worked for?
Sushmitha Sampath has worked for Nevro, Regulatory Affairs Professionals Society (Raps), Medtronic, University Of Southern California, and Lac + Usc Medical Center.
How can I contact Sushmitha Sampath?
You can use AeroLeads to view verified contact signals for Sushmitha Sampath at Nevro, including work email, phone, and LinkedIn data when available.
What schools did Sushmitha Sampath attend?
Sushmitha Sampath holds Master'S Degree, Bioengineering And Biomedical Engineering from University Of Southern California.
What skills is Sushmitha Sampath known for?
Sushmitha Sampath is listed with skills including Microsoft Excel, Microsoft Powerpoint, Microsoft Office, Leadership, Research, Matlab, Microsoft Word, and Management.
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