Harsh Chaudhari

To secure a position in Regulatory Affairs department where I can apply my knowledge of CDSCO regulations, ISO 13485 standards, and medical device documentation to ensure regulatory compliance and support successful product approvals.

Regulatory Affairs (DCGI) Officer at Meril Medical Innovation Pvt. Ltd. (2025-01 – Present)

• To prepare the file required for DCGI approval.
• Prepare and submission of Test License and Import license on MD portal.
• Preparation of DMF (Device Master File) of assigned project.
• Preparation of Instruction for Use / User manual of assigned projects.
• Preparation of DHF (Design History file).
• Risk Analysis for assigned projects
• Submission of Post approval.
• To communicate & develop artwork design. i.e., Brand name, Logo & Outer box design for R&D products with marketing team

Regulatory Affairs Validation Officer at Premier Medical Corporation Pvt. Ltd. (2023-06 – 2024-12)

• Prepared and submitted WHO design change dossiers for lancets and auto lancets.
• Handled WHO query responses related to prequalification submissions.
• Conducted and monitored calibration, validation, and mapping activities.
• Verified calibration and validation certificates.
• Assisted in drafting clinical evaluation study documents.

M.Sc. in Biotechnology – M.G.M Institute of Bio-Sciences (2022)

B.Sc. in Microbiology – Moolji Jetha College (2019)