Jai Prashanth K B Email & Phone Number

Chennai, Tn, In

Sholinganallur, Tamil Nadu, India

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.• Acquired extensive knowledge in SaMD and IEC 62304 standards, contributing through white paper.• Post-market Surveillance - Possess extensive knowledge in complaint intake and reporting processes.• Proposed innovative concepts for patent consideration, securing organizational endorsement.• Proposed and implemented automation tools, enhancing project efficiency.Risk Assessment:• Skilled in conducting Failure Mode and Effects Analysis (FMEA) for risk assessment and mitigation.• Proficient in Corrective and Preventive Action (CAPA) procedures to enhance quality management practices.Products Handled:• Class A, B and C IVD products in Molecular, Point-of-care Testing (POC), Microbiology and Women's health and care (WHC).• Managed specimen management products, including blood collection tubes, ensuring regulatory compliance.

Sholinganallur, Tamil Nadu, India

• 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.• Played a pivotal role in preparing lab-based technical documentation in accordance with Good Documentation Practices (GDP)• Developed and implemented Standard Operating Procedures (SOPs), ensuring streamlined processes and adherence to industry best practices, contributing to operational efficiency.• Demonstrated knowledge and proficiency in applying CLSI Standards and MDCG guidelines, ensuring their effective implementation for optimal laboratory practices and regulatory compliance.• EU IVDR/MDR Remediation and Sustenance Activity Quality Management:• Ensured adherence to ISO 13485 standards for quality management systems.• Applied ISO 14971 for risk management in medical devices.• Maintained compliance with US FDA 21 CFR 820 quality system regulations.• MQMSProducts handled:• Auto-immunoanalyzer:- Conducted clinical performance studies for thyroid function test • Blood gas analyzer:- Conducted comprehensive case studies, field studies, and analysed device recalls to ensure product reliability and compliance with regulatory standards

Btech - Bachelor Of Technology, Biotechnology

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