Vishalini B
Medical Device Quality and Regulatory Professional | PMS |Complaint handling | Tech file | MDR Gap assessment| EU MDR 2017/745 | 21 CFR 820, 803 | Certified Internal Auditor ISO 13485:2016
- Role
- Associate Mdr Vigilance Specialist at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Vishalini B
Detail-oriented Quality & Regulatory Affairs Professional with 3+ years of experience in Regulatory, Post-Market Surveillance (PMS) and Complaint Handling for medical devices across US, EU, LATAM, APAC, and Japan markets.Experienced in managing end-to-end complaint handling processes — intake, assessment, investigation, root cause analysis (RCA), CAPA, and closure — ensuring compliance with FDA 21 CFR 803/820, EU MDR 2017/745, and ISO 13485. Skilled in preparing Medical Device Reports (MDRs), Vigilance reports, and maintaining regulatory documentation for audits and inspections.Proficient in risk management (ISO 14971), GSPR compliance, technical documentation, and product lifecycle management. Hands-on experience with tools such as TrackWise, MasterControl, JDE, and Power BI for complaint tracking and quality data analysis.Strong knowledge of quality systems, CAPA management, FMEA, Good Documentation Practice (GDP), Verification & Validation (V&V), and medical device standards including IEC 60601, IEC 62366, and IEC 62304.Certified ISO 13485:2016 Internal Auditor (TÜV India) with a proven track record of supporting global regulatory compliance, continuous improvement, and product safety initiatives.
Experience
Associate Mdr Vigilance Specialist
Nov 2025 — Present · Hyderabad, IN
Education
DHAANISH AHMED INSTITUTE OF TECHNOLOGY
Bachelor of Engineering - BE, Biomedical/Medical Engineering
2018 — 2022
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