Subhashree Ramesh
Junior Associate QA/RA
Tiruchirappalli
Summary
Enthusiastic and detail-oriented Junior Quality Assurance & Regulatory Affairs professional with 1 year of experience supporting compliance activities. Familiar with document control, ISO 13485 and other regulatory standards. Eager to contribute and assist cross-functional teams in ensuring regulatory and product compliance.
Overview
1
1
year of professional experience
2
2
Certifications
Work History
Junior Associate QA/RA
Elettra Tech Labs (IMQ India)
02.2025 - 02.2026
- Contributed to successful project completion by tracking progress and updating team members regularly.
- Supported regulatory activities for medical device projects, assisting with DHF, RMF, and other files.
- Assisted in regulatory submissions and documentation, gaining hands-on exposure to compliance processes.
- Coordinated with teams to ensure the accuracy and completeness of regulatory files, in alignment with ISO 13485 and applicable regulatory guidelines.
Education
B.E - Biomedical Engineering
Dhanalakshmi Srinivasan Institute of Technology
Tiruchirappalli, Tamil Nadu05-2024
HSC -
Periyar Centenary Memorial Matriculation Hr.sec.school
Trichy, Tamil Nadu03-2020
SSLC -
Periyar Centenary Memorial Matriculation Hr.sec.school
03-2018
Skills
- ISO 13485 (QMS)
- ISO 14971(Risk Management)
- Documention
- CAPA
- IEC 60601-1
- EU MDR
- 21 CFR Part 820
- Communication
- Problem Solving
- Team Work
Certification
NPTEL- Tissue Engineering
PRESENTATIONS
- 2022 - National Level Technical Symposium organized by Dhanalakshmi Srinivasan engineering
- 2024 - 3rd National conference on SRM TRP Engineering college
INTERNSHIPS
- Apollo Speciality Hospitals, Trichy (02nd Jan 2023-8th Jan 2023)
- Apollo Speciality Hospitals, Trichy (11th July 2023 -15th July 2023)
- Mahatma Gandhi memorial Government Hospital, Trichy (Sep 2024-Oct 2024)
- Ministry of Health, Victoria Hospital, Mahe, Seychelles (Nov 2024-Dec 2024)
Timeline
Junior Associate QA/RA
Elettra Tech Labs (IMQ India)
02.2025 - 02.2026
B.E - Biomedical Engineering
Dhanalakshmi Srinivasan Institute of Technology
HSC -
Periyar Centenary Memorial Matriculation Hr.sec.school
SSLC -
Periyar Centenary Memorial Matriculation Hr.sec.school