Sathish Kumar C

Experience

1. Mdr Vigilance Specialist ll

   美敦力

   Jan 2023 — Present · Hyderabad, IN

   Strong expertise in complaint handling – from intake to closure – with deep knowledge of root cause analysis, risk mitigation, and CAPA implementation. Ensure conformity of medical devices with 21 CFR Part 820, EU MDR, ISO 13485, and ISO 14971, aligning with internal QMS procedures. Evaluate and report adverse events to global agencies including MDR (FDA), MIR (EUDAMED), and country-specific regulatory bodies. Perform structured risk investigations using 5 Why analysis, Fishbone, and product failure analysis to drive improvements and minimize recurrence. Developed and managed dashboards to improve process efficiency, track complaint trends, field actions, reportable errors, and regulatory metrics. Specialized in clinical evaluation, vigilance reportability assessments, risk-benefit analysis, and post-market risk updates. Lead and support audit readiness and compliance through ISO 13485:2016 and FDA QSR frameworks; certified ISO 13485 Lead Auditor. Collaborate with cross-functional teams (RA, QA, R&D, Clinical, Manufacturing) to ensure timely complaint resolution and regulatory compliance. Experience in both US and OUS markets with a proven ability to adapt to global regulatory environments.

Education

• Visvesvaraya Technological University

  Bachelor of Engineering - BE

  2011 — 2015