Nakshathra

Biomedical Engineering graduate with hands-on medical device industry experience as a Product Specialist. Seeking an entry-level role in Regulatory Affairs and Quality Assurance with a focus on medical device compliance and quality management systems. Proficient in CDSCO regulations, ISO 13485, ISO 14971 risk management, EU MDR, and post-market surveillance. Demonstrated ability to work in clinical environments, manage quality documentation, and coordinate cross-functional teams.

Product Specialist — Medical Devices - Phoenix Medicare Pvt Ltd - Bengaluru

(2025-05)

• Assisted spine surgeons in 75+ surgical procedures, ensuring correct device selection, sterile availability, and strict protocol adherence per device usage guidelines.
• Maintained comprehensive post-operative documentation and device utilisation records, improving workflow efficiency by 15% — supporting traceability and post-market surveillance objectives.
• Supported cardiology product adoption across 5+ hospitals; collected and systematised clinical feedback and coordinated with R&D and regulatory teams for product improvement.
• Increased qualified sales leads by 20% through structured product demonstrations and clinical education sessions for healthcare professionals.
• Applied ISO 13485 QMS principles to ensure documentation practices met internal quality standards and customer requirements.

B.Tech - Biomedical Engineering - Puducherry Technical University (2020-09 - 2024-07)