Amrutha Raja

B.M.S. College of Engineering: Medical Electronics, B.E.

Texas A&M: Biomedical Engineering, M.Eng.

Amrutha Raja currently serves as a Quality and Regulatory Affairs Associate II at Proxima Clinical Research, Inc.  Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Amrutha served in the Quality and Regulatory Affairs departments as a Regulatory Affairs Associate for a medical device company where she was charged with authoring SOPs, QOPs, taking part in Internal Audits, reviewing Change Orders, and approving design documentation as the Quality and Regulatory representative on multiple projects.

Proxima Clinical Research, Inc., Houston, Texas
Quality and Regulatory Affairs Associate II

Biotex, Inc., Houston, Texas
Regulatory Affairs Associate

Ms. Raja has played an important role in the development of the following medical products:

1. Medical Device – Device to prevent Ventilator Associated Pneumonia
2. Medical Device - Neonatal CPAP  
3. Medical Device - Minimally Invasive Cardiac Assist Device
4. Medical Device – Surgical Drill
5. Medical Device - Robot Assisted Cochlear Implantation Device
6. Medical Device - Surgical Luminaire
7. Medical Device – Bleed Detection System
8. Medical Device – Esophageal Temperature Monitoring System  
9. Medical Device – Trocar Wash Device
10. Medical Device – Vascular Access Device
11. Medical Device - Intraoral device for Sleep Apnea
12. Medical Device - Vaginal Stent

Honors Graduate

Best Paper Award at COMSNETS-2018

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