Summary
Overview
Work History
Education
Skills
Personal Information
Affiliations
Accomplishments
Languages
Websites
Key Strength
Timeline
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Vandana Sangam

Vandana Sangam

Jalna

Summary

Medical device professional with 2.5 years of experience in regulatory affairs and quality assurance.

Overview

3
3
years of professional experience

Work History

Senior Engineer - Regulatory Affairs

Tata Elxsi Ltd.
Pune
04.2024 - Current
  • EUMDR 2017/745: Technical documentation gap analysis and remediation mainly includes the workstreams such as GSPR, LOAS, product description, predecessor and competitive devices, risk management, PMS, PSUR, PMCF, label, IFU, biocompatibility, STED, and declaration of conformity (DoC), and Design Control Matrix.
  • Import License and Export License (FSC) application process and related forms.
  • Basic understanding of the Medical Device Complaint Handling Process, Software as a Medical Device (SiMD and SaMD), 7 QC tools, and the EU AI Act.

Operations Executive

Zenith Quality Assessors Pvt. Ltd.
Pune
08.2022 - 02.2024
  • Reviewed and aligned the Technical Files according to Regulation EU MDR 2017/745 to submit to the Notified Body.
  • Reviewed technical files for IMDR 2017 (CDSCO) as a notified body.
  • Which comprises Device description, Risk Management File, Design and Development, STED, Product Verification and Validation Documents (Performance Evaluation, Stability Data, Packaging Test, Basic Electric Safety Test Report, Software Test Report, Sterility Test Report), Clinical Evaluation Reports, PMS, PMCF, etc.
  • Medical Device Quality Management System (ISO 13485):
  • To conduct application review, audit planning, and audit team selection for Quality; to conduct Technical Review of Audit Reports of the Quality Management System (QMS) as per ISO 13485 - NC & CAPA.
  • Involved in the audit as per IMDR 2017 (Vth Schedule) and ISO 13485 as a trainee auditor.
  • Managing the project from the filling of the application form to the project disposal to the Notified Body/CDSCO.

Education

M. Tech - Medical Devices

NIPER
Guwahati
06-2022

B. Pharm -

Govt. College of Pharmacy
Aurangabad
06-2020

Skills

  • EUMDR 2017/745
  • IMDR 2017 (CDSCO)
  • ISO 13485
  • ISO 14971
  • IEC 62366-1
  • ISO 15223-1
  • ISO 20417
  • IEC 62304
  • IEC 60601-1 and -2
  • MEDDEV 271
  • ISO 20417
  • ISO 10993

Personal Information

  • Date of birth: 10/06/98
  • Nationality: Indian

Affiliations

  • Participated in the intra-college cricket match
  • Participated in a tree plantation activity

Accomplishments

  • Got an appreciation badge for collaboration and ownership

Languages

English
Intermediate (B1)
B1
Hindi
Intermediate (B1)
B1

Key Strength

  • Hard working
  • Positive attitude
  • Strong work ethic
  • Active listening

Timeline

Senior Engineer - Regulatory Affairs

Tata Elxsi Ltd.
04.2024 - Current

Operations Executive

Zenith Quality Assessors Pvt. Ltd.
08.2022 - 02.2024

M. Tech - Medical Devices

NIPER

B. Pharm -

Govt. College of Pharmacy

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Vandana Sangam