Who is Jai Prashanth K B? Overview
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Quick answer
Jai Prashanth K B is listed as Regulatory Analyst at HCLTech, based in Chennai, Tamil Nadu, India. AeroLeads shows a matched LinkedIn profile for Jai Prashanth K B.
Jai Prashanth K B previously worked as Graduate Engineer Trainee at Hcltech. Jai Prashanth K B holds Btech - Bachelor Of Technology, Biotechnology from Jeppiaar Engineering College.
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Email format at HCLTech
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HCLTech
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Profile bio
About Jai Prashanth K B
At HCLTech, my role as a Regulatory Analyst centers on steering Class A, B, and C IVDs and medical devices through the IVDR transition and MDR, backing our team's efforts to maintain compliance and mastermind regulatory strategies. A B.Tech in Biotechnology underpins my proficiency in IVD testing, enhancing our pursuit of excellence in specimen management and diagnostics.My focus is on crafting robust regulatory submissions for innovative medical devices, maintain Quality Management System (QMS) - ISO 13485, QSR, CDSCO, risk management, ISO 14971, leveraging expertise in FDA 510(K) Submissions, SaMD and IEC 62304 standard. With a commitment to continuous professional growth, I ensure that our regulatory practices align with global benchmarks, striving to contribute to the advancement of medical technology.
Current workplace
Jai Prashanth K B's current company
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3 roles
Jai Prashanth K B work experience
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Regulatory Analyst
Current- At BD (Beckton, Dickinson and Company):
- Actively contributed to remediation and sustenance projects during the IVDR transition for Class A, B, and C IVD products, including drafting technical files and PER Toolkits.
- Managed diagnostics and specimen management products, ensuring compliance and smooth transitions.
- Authored and reviewed regulatory submission documents for new product development in specimen management.
- Developed and executed regulatory strategies to ensure successful submissions and compliance with global regulations.
- Demonstrated expertise in FDA 510(k) submissions, MDD 93/42/EEC compliance, and 21 CFR 820 Quality System regulations.
Jan 2024 - Present
Graduate Engineer Trainee
- Proficient in IVD Testing, EU 2017/745 MDR, EU 2017/746 IVDR, Regulatory Compliance, FDA Regulations, ISO Standards
- Specialized in verification and validation methods, performance evaluation, Clinical compliance handling.
- Executed Clinical Performance Studies for IVD instruments in compliance with ISO 20916:2021, ensuring thorough evaluation and validation performance.
- Coordinated staff training, managed clinical samples, and maintained instrument performance(QC, Calibration and maintenance).
- Played a key role in ISO 13485 lab audit, contributing to successful accreditation
- Conducted comprehensive case study preparation and presentation on various blood gas analyzers available in the market, which included extensive field studies and handling recalls of medical devices.
Sep 2022 - Dec 2023
3 education records
Jai Prashanth K B education
Btech - Bachelor Of Technology, Biotechnology
12Th
10Th
Bright Minds Vidyodaya
FAQ
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Quick answers generated from the profile data available on this page.
What company does Jai Prashanth K B work for?
Jai Prashanth K B works for HCLTech.
What is Jai Prashanth K B's role at HCLTech?
Jai Prashanth K B is listed as Regulatory Analyst at HCLTech.
Where is Jai Prashanth K B based?
Jai Prashanth K B is based in Chennai, Tamil Nadu, India while working with HCLTech.
What companies has Jai Prashanth K B worked for?
Jai Prashanth K B has worked for Hcltech.
How can I contact Jai Prashanth K B?
You can use AeroLeads to view verified contact signals for Jai Prashanth K B at HCLTech, including work email, phone, and LinkedIn data when available.
What schools did Jai Prashanth K B attend?
Jai Prashanth K B holds Btech - Bachelor Of Technology, Biotechnology from Jeppiaar Engineering College.
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