Shital Auti
Technical Lead at HCL Tech
- Role
- Technical Lead at HCLTech
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Shital Auti
Prepared and submitted [X number] of successful Traditional and Abbreviated 510(k) submissions for Class II devices.Developed regulatory strategies based on device classification, intended use, and technological characteristics.Compiled complete 510(k) dossiers including Executive Summary, Device Description, Substantial Equivalence Comparison, and Summary of Clinical Data.Coordinated with Product Development teams for gathering Design History Files (DHF) and Technical Documentation.Led responses to FDA Additional Information (AI) Letters within regulatory deadlines.Conducted gap assessments of existing 510(k)s for legacy devices.Reviewed and approved labeling, Instructions for Use (IFU), and promotional materials for regulatory compliance.Supported preparation for FDA inspections and internal audits related to regulatory submissions.
Experience
Technical Lead
Aug 2025 — Present · Hyderabad, IN
Education
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm
2015 — 2018
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