Nakshathra

About

Biomedical Engineering graduate with hands-on experience in the medical device industry as a Product Specialist and currently working as a Quality Assurance and Regulatory Affairs Intern. Interested in regulatory affairs, quality assurance, medical device compliance, and quality management systems.

Experience

• Quality Assurance & Regulatory Affairs Intern
  BrainsightAI
  Jul 2026 – Present
• Product Specialist
  Phoenix Medicare Pvt Ltd
  May 2025 – Jun 2026

Education

• B.Tech
  Puducherry Technical University
  Biomedical Engineering · Sep 2020 – Jul 2024

Skills

• C
• Python
• Quality Assurance
• Regulatory Affairs
• Documentation Control
• Quality Reporting
• Audit Documentation
• Post-market Surveillance
• ISO 14971
• medical image processing
• medical device standards

Courses & certifications

• ISO 14971:2019 — Risk Management for Medical Devices · Udemy
• ISO 13485:2016 — Quality Management Systems for Medical Devices · Alison

📚 Publications

• Advanced surface electromyography (sEMG) signal analysis · 2024