Murugavel

Biomedical Engineering graduate with internship experience in medical device Regulatory Affairs across EU MDR, US FDA 510(k), and India CDSCO pathways, including MD-16/MD-17 import-licence support. Hands-on with ISO 13485 QMS documentation, ISO 14971 risk analysis, Device Description, and Substantial Equivalence. Seeking an entry-level QARA role to support quality systems, regulatory submissions, and product registrations.

QARA Intern at Perfint Healthcare Pvt Ltd (2026-04 – 2026-08)

• Drafted Device Description and Substantial Equivalence sections for a Class II 510(k) submission, cross-referencing predicate device data across 2 FDA clearances.
• Supported product identification workflows by assisting with GTIN creation on the GS1 Portal and submitting Form MD-16/MD-17 applications via the NSWS Portal.
• Collaborated with cross-functional teams to maintain regulatory trackers and monitor submission progress, pending items, and document status using Microsoft Excel.

Regulatory Affairs Intern at Medfins International LLP (2026-01 – 2026-03)

• Gained hands-on understanding of ISO 13485 QMS documentation; performed ISO 14971 risk analysis and developed FMEA tables.
• Assisted in preparing Device Master File and labelling documents.

Bachelor of Biomedical Engineering in Biomedical Engineering – Dhanalakshmi Srinivasan College of Engineering (2022 – 2026)

Higher Secondary – Govt Boys Higher Secondary School, Uthangarai (2021 – 2022)

Secondary – Govt Boys Higher Secondary School, Uthangarai (2019 – 2020)