Nikita Borade

Medical Device Regulatory Affairs Professional with 1.9 years of experience in CE (European Conformity), Regulatory Documentation, Product Registration and Compliance. Knowledge of EU MDR 2017, GSPR, Risk management, Technical Documentation and PMS. Strong attention to detail with focus on regulatory accuracy and timely submission.

Regulatory Affairs Officer at MERIL MEDICAL INNOVATION PRIVATE LIMITED (2024-12 – 2026-08)

• Experienced in preparing and reviewing regulatory dossiers for registration, approval and renewal procedures in the European Union (EU) market.
• Hands-on experience in compiling and reviewing regulatory documentation for EU market submissions, including preparation of GSPR, LOS, MPQC, Usability Engineering, Risk Management Reports, Technical Documentation, Technical Comparisons, Packaging Descriptions, IFU and Review of Label.
• Cross-Functional Coordination with other departments (QA, QC, Production etc.)
• Validation Activities.
• Strong understanding of key regulatory bodies and guidelines for medical devices, including EU, USFDA, CDSCO, ISO 13485, and DCGI requirements.
• Knowledge of medical device classification and categorization, with awareness of products such as stents, balloon catheters, diagnostic tools, cardiac surgery equipment, and orthopedic implants.

Master of Pharmacy – DVVPF’s COP Ahmednagar (2024)

Bachelor of Pharmacy – MGV’s Pharmacy college, Nashik (2022)

HSC – MVP Makhamalabad Nashik (2018)

SSC – GES HAL high school, Nashik (2016)