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Jeevitha Sankar Email & Phone Number

Quality Assurance and Regulatory Affairs Lead at HCLTech
Location: Greater Chennai Area, India, India 5 work roles 2 schools
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Current company
Role
Quality Assurance and Regulatory Affairs Lead
Location
Greater Chennai Area, India, India

Who is Jeevitha Sankar? Overview

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Quick answer

Jeevitha Sankar is listed as Quality Assurance and Regulatory Affairs Lead at HCLTech, based in Greater Chennai Area, India, India. AeroLeads shows a matched LinkedIn profile for Jeevitha Sankar.

Jeevitha Sankar previously worked as Quality Assurance & Regulatory Affairs Lead at Hcltech and Senior Product Regulatory Analyst at Hcl Technologies. Jeevitha Sankar holds Master Of Engineering - Meng, Medical Electronics from Sri Sivasubramaniya Nadar College Of Engineering.

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HCLTech

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About Jeevitha Sankar

Jeevitha Sankar is a Quality Assurance and Regulatory Affairs Lead at HCLTech. They possess expertise in microsoft word, microsoft office, microsoft excel, leadership, powerpoint and 2 more skills.

Listed skills include Microsoft Word, Microsoft Office, Microsoft Excel, Leadership, and 3 others.

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Jeevitha Sankar's current company

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HCLTech
Hcltech
Quality Assurance and Regulatory Affairs Lead
Chennai, TN, IN
AeroLeads page
5 roles

Jeevitha Sankar work experience

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Quality Assurance And Regulatory Affairs Lead

Chennai, TN, IN

Quality Assurance & Regulatory Affairs Lead

Current

Quality Management Systems: Participated in product standards and regulations compliance internal audits/reviews of the assigned product and make necessary modification as required and active participant in accredited external compliance audits (ISO 13485, CMMI Level 5) for each of the identified products. Prepared relevant Work Instructions and SOPs for.

Dec 2023 - Present

Senior Product Regulatory Analyst

Chennai, Tamil Nadu, India

  • Strong knowledge in IEC62304 - Medical device software – Software life cycle processes
  • Strong Knowledge on application development with Software Development Life Cycle SDLC using methodologies like Agile/Scrum
  • Worked in-parallel on the development of multiple Medical Device software projects that includes SaMD/Standalone Software, SiMD (Software in Medical Device), IVD & Non-IVD Software, Service Software, Companion.
  • Software Safety Classification evaluation is performed as per IEC62304 and Preparing related product specific document for IVD/MD Software
  • Planning & Executing the Risk management activities as per ISO14971 inclusive of Risk management plan, Hazard analysis, DFMEA, PFMEA, Risk Management Report, Benefit-Risk analysis.
  • Ensuring Medical device compliance to Usability requirements as per IEC62366-1 and Usability approach for Medical Device Software.
Mar 2021 - Nov 2023

Visiting Assistant Professor

Niepmd, Central Govt. Of India

Chennai, Tamil Nadu, India

 Developed online course models as per college policies Encouraged class discussions by building discussions into lessons, actively soliciting input, asking open-ended questions and using techniques to track student participation. Used variety of learning modalities and support materials to facilitate learning process and accentuate presentations.

Mar 2020 - Dec 2020

Junior Research Fellow

Chennai, Tamil Nadu, India

  • Developed a speech recognition system using HMM toolkit (Tamil Language) for person with cerebral palsy, to overcome the communication barrier (implemented in Raspberry Pi, for real-time recognition applications)
  • Recorded data from research to allow for accurate analysis.
  • Designed and carried out complex laboratory experiments to assess effectiveness of Speech Recognition
  • Performed scientific research on multiple projects.
Sep 2018 - Sep 2019
2 education records

Jeevitha Sankar education

FAQ

Frequently asked questions about Jeevitha Sankar

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What company does Jeevitha Sankar work for?

Jeevitha Sankar works for HCLTech.

What is Jeevitha Sankar's role at HCLTech?

Jeevitha Sankar is listed as Quality Assurance and Regulatory Affairs Lead at HCLTech.

Where is Jeevitha Sankar based?

Jeevitha Sankar is based in Greater Chennai Area, India, India while working with HCLTech.

What companies has Jeevitha Sankar worked for?

Jeevitha Sankar has worked for Hcltech, Hcl Technologies, Niepmd, Central Govt. Of India, and Ssn College Of Engineering.

How can I contact Jeevitha Sankar?

You can use AeroLeads to view verified contact signals for Jeevitha Sankar at HCLTech, including work email, phone, and LinkedIn data when available.

What schools did Jeevitha Sankar attend?

Jeevitha Sankar holds Master Of Engineering - Meng, Medical Electronics from Sri Sivasubramaniya Nadar College Of Engineering.

What skills is Jeevitha Sankar known for?

Jeevitha Sankar is listed with skills including Microsoft Word, Microsoft Office, Microsoft Excel, Leadership, Powerpoint, Research, and Project Management.

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