Sahil Zagade Email and Phone Number
As a System Engineer at Tata Consultancy Services, I specialize in EU-MDR compliance, CE Marking, and Global Registrations for medical devices. I have over 2.9 years of notable contributions in the Medical Device Domain.I am proficient in CFG creation, Label Verification, UDI Data Cleansing, RAC & RAN pathways, and STeD documentation. I have extensive knowledge of ISO 13485 and US FDA Regulations, as well as Microsoft Power BI and Microsoft Azure. I also hold a Six Sigma White Belt certification and have skills in Supplier Quality Management, CAPA, Quality Assurance, and Process Improvement. I am passionate about navigating regulatory landscapes and driving successful product launches.
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System EngineerTata Consultancy Services Nov 2023 - PresentNagpur, Maharashtra, India1. Proficient in supporting EU-MDR documentation and CE Marking Approval processes for Medical Devices in compliance with European Union regulations.2. Skilled in creating CFG (Certificate to Foreign Government) and providing support for Global Product Registrations, ensuring compliance with regulatory requirements for medical devices across multiple markets.3. Experienced in Label Verification Activities for diverse geographic regions, ensuring adherence to regulatory standards and market-specific labeling requirements for medical devices. -
Assistant System EngineerTata Consultancy Services Nov 2022 - Nov 20231. Skilled in UDI Data Cleansing, ensuring data accuracy and compliance.2. Proficient in creating RAC/RAN documentation, guiding regulatory pathways.3. Experienced in crafting STeDs for concise technical documentation.
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Assistant System Engineer TraineeTata Consultancy Services Nov 2021 - Nov 2022Nagpur, Maharashtra, IndiaExperienced professional at Medtronic adept in managing Supplier Quality Agreements (SQAs) with key suppliers. Skilled in negotiating, drafting, and amending SQAs while ensuring cross-functional alignment and regulatory compliance. Proficient in facilitating supplier negotiations, conducting periodic reviews, and implementing necessary actions for SQAs. Experienced in collaborating across teams and approving data changes related to SQAs.
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TraineeSpicer India Ltd Nov 2020 - Mar 2021Chakan, Maharashtra, India
Sahil Zagade Education Details
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Goverment Polytechnic Murtizapur82.24 %
Frequently Asked Questions about Sahil Zagade
What company does Sahil Zagade work for?
Sahil Zagade works for Tata Consultancy Services
What is Sahil Zagade's role at the current company?
Sahil Zagade's current role is System Engineer | Regulatory Affairs, Medical Device Directive | TCS.
What schools did Sahil Zagade attend?
Sahil Zagade attended Prof. Ram Meghe Institute Of Technology & Research Badnera Rly., Goverment Polytechnic Murtizapur.
Who are Sahil Zagade's colleagues?
Sahil Zagade's colleagues are Haladhara Pradhan, Hemalatha Sabbisetty, Jagadeesh Chennuru, Nicolas Lemes Melo De Moura(Pcd), Balasingam Thirunavukkarasu, Meenal Sahu, Mohanram A.
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