Pranit Ravuri

Regulatory Specialist II at Nevro
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Tracy, California, United States, US
Languages
  • Telugu Native or bilingual proficiency
  • English Native or bilingual proficiency
  • Spanish Limited working proficiency

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Green Jobs for Sustainable Careers
    LinkedIn
    Dec, 2022
    - Nov, 2024
  • Introduction to LEED Credentialing
    LinkedIn
    Dec, 2022
    - Nov, 2024
  • Organizing Your Office for Maximum Efficiency
    LinkedIn
    Dec, 2022
    - Nov, 2024
  • Excel Essential Training (Office 365/Microsoft 365) Getting started with Excel for Office 365
    National Association of State Boards of Accountancy (NASBA)
    Aug, 2022
    - Nov, 2024
  • Cert Prep: Certified SOLIDWORKS Associate
    LinkedIn
    Jul, 2021
    - Nov, 2024
  • Remote Work Foundations
    LinkedIn
    Dec, 2020
    - Nov, 2024
  • RAPS Member
    Regulatory Affairs Certification Program
    Apr, 2020
    - Nov, 2024

Experience

  • Nevro
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Regulatory Specialist II
      • Oct 2021 - Present

      • Assess Regulatory impact and develop action plans for Supplier Change Notifications • Build responses to BSI MDR Technical Questions through a cross functional team • Build Real Time Review Submission to FDA for implementation of alternate device power source • Coordinate Manufacturer responses to MDR Submission BSI Reviewer questions • Assess Regulatory impact and develop action plans for Supplier Change Notifications • Build responses to BSI MDR Technical Questions through a cross functional team • Build Real Time Review Submission to FDA for implementation of alternate device power source • Coordinate Manufacturer responses to MDR Submission BSI Reviewer questions

  • Johnson & Johnson MedTech
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Regulatory Submissions Specialist
      • Nov 2020 - Sep 2021

      • Supported Test fixture development to system engineer teams in verification activities • Perform Ad Hoc testing by driving Robotic Bronchoscopy systems in a lung model and provide user experience feedback to systems teams • Reviewed biocompatibility, sterility, packaging, validation, verification plans and provide feedback from a FDA perspective • Observe and provide regulatory feedback on mechanical and animal testing for robotic bronchoscopy system • Created and updated technical documentation following Good Documentation Practices, applicable standards and FDA guidance for assessing regulatory impact to design changes, manufacturing changes, preparing FDA submissions • Substantially involved in successful Special 510(k) submission, K211493, for Monarch Platform Robotic Bronchoscopy System Show less

  • Auris Health, Inc.
    • United States
    • Hospitals and Health Care
    • 100 - 200 Employee
    • Regulatory Affairs Specialist
      • Nov 2019 - Oct 2020

      • Substantial involvement in Traditional 510(k) Submission, K193534, for Robotic Endoscopy Device • Technical document writing and revision with FDA guidance compliance; Letter to File, QSUB and RFAI • Coordinate with UDI experts to build UDIs for new product codes • Cooperate with Regulatory Affairs counterparts in China and Canada for product clearance • Crucial in Regulatory Infrastructure and Standard Operating Processes Development • Provide communication between Regulatory Affairs and product development teams Show less

  • Varian
    • United States
    • Medical Device
    • 700 & Above Employee
    • Regulatory Submissions Intern
      • Jun 2019 - Sep 2019

      - EU MDR Classification and International Standards Compliance - International Submission Dossier building and maintenance - Coordination and research between product team and corporate regulatory affairs - Complete Health Canada Submissions and Device Gap Assessments - EU MDR Classification and International Standards Compliance - International Submission Dossier building and maintenance - Coordination and research between product team and corporate regulatory affairs - Complete Health Canada Submissions and Device Gap Assessments

  • San Jose State University
    • United States
    • Higher Education
    • 700 & Above Employee
    • Research Scholar
      • Sep 2018 - May 2019

      • Created wearable ECG for activity tracking, energy expenditure and stress monitoring compatible with BIOPAC • Designed, evaluated and 3D printed test fixtures for hybrid PPG systems to evaluate viability for improved diagnostic results and determine appropriate study subject positioning for results collection • Created and executed comparative testing protocols of custom-built ECG and commercial ECG devices 􀀀 Created protocols for simultaneous data gathering of two wearable devices 􀀀 Develop Bluetooth connection workarounds • Performed MATLAB R-squared analysis and regression line matching for relationship determination • Improved modular home-built research grade ECG for future development and improved accuracy of collected raw data Show less

  • Destination Science
    • Los Altos, California
    • Teacher
      • Jun 2017 - Aug 2017

      Teaching children scientific concepts and basics while also guiding them through experiments to materialize and reinforce concepts being introduced to children. Teaching children scientific concepts and basics while also guiding them through experiments to materialize and reinforce concepts being introduced to children.

Education

  • San Jose State University
    Bachelor’s Degree, Bioengineering and Biomedical Engineering
    2014 - 2019

Community

You need to have a working account to view this content. Click here to join now