Nivetha S
Senior Regulatory affairs Engineer for medical devices
- Role
- Regulatory Analyst at Cyient
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Nivetha S
Currently working as a Senior Regulatory affairs Engineer with 3 years of experience in labeling and Packaging (L&P), Compliant handling and PMS project to make medical devices compliant with respect to Medical Device Regulation 2017/745 of the European Union (EU MDR), US-FDA and relevant ISO standards.Basic understanding of medical device standards like EU MDR Compliance (Regulation EU 2017/745),ISO 13485, ISO 15223, ISO 14971, and 21 CFR, Compliant handling, CAPA, PMS activities & PSUR, GSPR.
Experience
Regulatory Analyst
Dec 2025 — Present · Pune, IN
Education
Symbiosis Centre for Distance Learning
Postgraduate Degree
2023 — 2026
CEOA
High school
2016 — 2018
Mepco Schlenk Engineering College
Bachelor of Technology - BTech
2018 — 2022
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