Manoj Borase
Sr. Engineer Regulatory Affairs @ Tata Elxsi | SaMD I SiMD I US FDA I ISO 13485:2016, 21 CFR 820, EUMDR 2017/745, ISO 14971, IEC62304 IEC62366, & Global Submissions.
- Role
- Sr Engineer Regulatory Affairs at Tata Elxsi
- Location
- Dhule, MH, IN
- LinkedIn followers
- 500 followers
About Manoj Borase
A BE Mechanical graduate from Savitribai Phule Pune University, I now apply my expertise…
Experience
Sr Engineer Regulatory Affairs
Sep 2023 — Present · Pune, IN
GSSD (Global Submission Summary Documentation) STED creation includingsummary of technical documentation and folder structure for supportingevidences (Cardiac surgery products including prosthetic heart valve,devices involved in cardiopulmonary surgeries etc.)Collaboration with Geography RA for assessing impact of MDD to MDRtransition and for supporting submission for MDR complaint productConfiguration.Preparation of submission dossiers for product registration in APAC, EMEA,LATAM and Other regions.Creation of GSSD STED, Country specific submission dossiers.Collaboration with Geography RA for UFC query resolution of EU MDR2017/745.Knowledge of ISO 13485:2016, 21 CFR 820, 510K process, de novo and PMAprocess of FDA submission.Support in creation and technical review of risk management documents asper the ISO 14•••••19.Knowledge of Agile PLM Tools for documentation.Country regulation specific folder creation for UFC and GSSD.
Education
Savitribai Phule Pune University
BE MECHANICAL
2013 — 2017
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