Urja A.
QA/RA (Medical Devices) | ISO 13485 | Regulatory Submissions Blending RA and QA engineering to ensure safe, compliant and effective medical devices.
- Role
- Regulatory Affairs Associate at Artixio
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Urja A.
Regulatory Affairs and Quality professional in the medical device industry with direct experience across design quality, regulatory submissions, and QMS activities for global markets.My work involves translating RA/QA requirements into product design and development needs, V&V and post-market processes, with hands-on exposure to ISO 13485, FDA 21 CFR Part 820/QMSR, and EU MDR.Previously at Tata Elxsi, I worked on V&V documentation reviews, design control support, and risk-based quality activities for medical devices for the US market. Currently at Artixio, I support regulatory submissions, technical and QMS documentation, design and risk file reviews for medical devices across multiple markets.
Experience
Regulatory Affairs Associate
Nov 2024 — Present · Hyderabad, IN
Education
MIT ADT University
Master's, Bioengineering and Biomedical Engineering
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