Balasangeetha S M
Analyst - Regulatory affairs | Senior Data Analyst | Medical devices | EU MDR | EUDAMED | ISO 13485 | ISO 14971 | ISO 15223 | PMS | MD RIM
- Role
- Analyst - Regulatory Affairs at HCLTech
- Location
- Madurai, IN
- LinkedIn followers
- 500 followers
About Balasangeetha S M
Passionate Medical device professional with 3+ years of experience in Medical Device Regulatory Affairs especially in EU MDR, EUDAMED, IVDR, ISO 13485, ISO 14971, ISO 15223, 21 CFR 820, GSPR & Technical Documentation, Post Market Surveillance and MD RIM Data Remediation projects.
Experience
Analyst - Regulatory Affairs
Feb 2022 — Present · Madurai, IN
Education
Institute of Good Manufacturing Practices India (IGMPI)
EXECUTIVE DIPLOMA, MEDICAL DEVICE MANAGEMENT (Regulatory affairs), 9.05 CGPA
2022 — 2023
Alagappa University
Master of Science - MS, Biotechnology, 73%
2017 — 2019
THIAGARAJAR COLLEGE
Bachelor of Science - BS, Biotechnology, 72%
2014 — 2017
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