Summary
Overview
Work History
Education
Core qualifications :
Languages
Timeline
Generic
Vibin.G

Vibin.G

City - Coimbatore

Summary

  • Creation of Periodic safety update report (PSUR) and Post market surveillance report (PMSR) for both US FDA and EU MDR
  • Creation of Risk management file with respect to ISO 14971:2019
  • EU MDR 2017/745 tech file remediation for urological critical care and Pen injector
    devices.
  • Developing and maintaining CAPA (Corrective and preventive action) quality
    systems and providing CAPA/NC solutions for business units.
  • Experienced in drafting Design verification,Validation protocols and also verifying
    the reliability of hardware and software medical devices.
  • Conducted QMS (ISO 13485:2016 & ISO 9001:2015) internal audits.

Overview

8
8
years of professional experience

Work History

Quality and Regulatory Specialist

Dedalus
10.2023 - Current
  • Technical expertise acquired : Performing quality audits, SOP creation, Quality manual creation.
  • Conducting ISO 13485:2016 & ISO 9001:2015 audits to the team and representing my team to face to face any external audits.
  • Creation of quality manual, CAPA and audit procedures.
  • Lead quality team to ensure product/process meet all the regulatory requirements such as IEC 62304:2006/AMD 1:2015.

Senior Engineer

Freyr Solutions
12.2021 - 09.2023
  • Technical expertise acquired : Post market surveillance, Periodic safety update report (PSUR),Development safety update report (DSUR),Risk management (ISO 14971:2019),Vigilance reporting ,Design history file (DHF),Software life cycle process (IEC 62304), CAPA, ISO 13485:2016 and 21 CFR 820.
  • Creation of periodic safety update reports (PSUR) , development safety update report (DSUR) and co-ordinate with Marketing authorization holders to market the product at post authorization phase.
  • Performed and delivered Risk management plans (RMP) Preliminary hazard analysis, (PHA), FMEA, Risk analysis for Hardware and SaMD products and created Risk management report aligning residual disclosure adhering to ISO 14971:2019.
  • Collaborated with cross functional teams to ensure software met regulatory requirements and complied with IEC 62304 standards.
  • Evaluates incoming complaint information and maintains the record in TrackWise (Electronic quality management system).Also, perform follow up activities to obtain additional information.
  • Collaborated with the project team for Design History File (DHF) preparation and compilation of Technical documents for regulatory submissions.

Member of Technical Staff

HCL Technologies
09.2018 - 12.2021
  • Technical expertise acquired : Drafting design verification protocol,EU MDR 2017/745, Conducting ISO 13485:2016 quality audit,CAPA and Labeling management.
  • Develop and execute Design Verification and Design Validation protocols for Pen injector devices to implement Engineering change or scope of the testing.
  • Worked on Tech file remediation for Urological critical care and Pen injector devices with respect to EU MDR 2017/745 for regulatory submission.
  • Conducted ISO 13485 audits to team members to represent my team to face external audits.
  • Developing and maintaining CAPA (Corrective and preventive action) quality systems and providing CAPA solutions for the business unit.

Graduate Engineer

L.G. Balakrishnan Bros Ltd
09.2016 - 08.2017
  • Technical expertise acquired : Quality inspection,Quality records and Bill of materials (BOM).
  • Preparation of quality reports by inspecting the products to make sure the manufactured product is compliant to the engineering drawing.
  • Possess knowledge in the blanking manufacturing process, mechanical aspects and a sound knowledge of quality tools.
  • Coordinating with cross functional teams to update BOM changes as needed.

Education

B.E - Mechanical Engineering

Sri Krishna College of Technology
Location - Coimbatore, Tamilnadu
2016

Core qualifications :

  • Quality management
    system (ISO 13485:2016
    , 21 CFR 820 & ISO
    9001:2015)
  • Risk management (ISO
    14971:2019)
  • Creation of periodic
    safety update report
    (PSUR)
  • Clinical evaluation
    report (CER)
  • Regulatory affairs
  • Design history file
    (DHF)
  • Complaint handling
  • CAPA
  • Medical device
  • Post market surveillance
  • US FDA
  • EU MDR

Tools Used :

  • Power BI
  • Trackwise
  • Minitab

Languages

English
Proficient
C2
Tamil
Proficient
C2
Telugu
Intermediate
B1

Timeline

Quality and Regulatory Specialist

Dedalus
10.2023 - Current

Senior Engineer

Freyr Solutions
12.2021 - 09.2023

Member of Technical Staff

HCL Technologies
09.2018 - 12.2021

Graduate Engineer

L.G. Balakrishnan Bros Ltd
09.2016 - 08.2017

B.E - Mechanical Engineering

Sri Krishna College of Technology

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Vibin.G