Krishna Mohan T V
Hyderabad
Summary
Quality and Post-Market Surveillance professional with over 18 years in the medical device sector, focusing on EU MDR compliance, FDA complaint management, and global vigilance reporting. Expertise in PMS, PMCF, PSUR, CAPA, and risk management (ISO 14971) for Class II and III devices in regulated environments. Demonstrated ability to lead cross-functional teams and develop inspection-ready quality systems that meet complex regulatory standards. Proven success in enhancing compliance processes and achieving favorable FDA and EU regulatory outcomes for global organizations, including Medtronic.
Overview
20
20
years of professional experience
1
1
Certification
Work History
MDR Vigilance Specialist
Medtronic
02.2023 - Current
- Led FDA and EU MDR vigilance, ensuring compliance with complaint management requirements.
- Maintained accurate complaint records in accordance with 21 CFR 820 and 803 standards.
- Conducted risk analysis and reportability assessments for adverse events and potential recalls.
- Authored detailed investigation summaries based on technical product analysis and risk documentation.
- Reviewed risk management files to ensure compliance with ISO 14971 principles for complaints.
- Supported global vigilance reporting and submissions to relevant regulatory authorities.
- Collaborated with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to enhance quality practices.
- Strengthened complaint handling processes, improving regulatory defensibility and inspection readiness.
Quality & Compliance Engagement
Encora Innovation Labs (Client: Wells Fargo)
Hyderabad
02.2022 - 02.2023
- Delivered quality and documentation support within regulated electronic systems, including SmartSolve and Wizard tools.
- Ensured accuracy, compliance, and traceability of documentation in controlled environments.
Senior Associate
Tech Mahindra Ltd
Hyderabad
10.2020 - 02.2022
- Supported quality-driven customer operations with strong process adherence.
- Applied analytical decision-making to improve service outcomes and compliance.
Customer Service Engineer / Process Associate
Sysnett Technology Solutions | Janaspandana Software Solutions
Hyderabad
03.2018 - 10.2020
- Established robust foundations in process discipline, documentation, and customer-oriented problem solving, later utilized in regulated quality environments.
Customer Quality Specialist (Google client)
Genpact
Hyderabad
02.2017 - 03.2018
- Managed end-to-end complaint handling, including intake, investigation, categorization, and closure.
- Determined safety impact and reportability, creating reportable and nonreportable investigation tasks.
- Maintained complaint records in TrackWise, adhering to Good Documentation Practices (GDP).
- Collaborated with cross-functional teams to resolve quality issues and implement CAPAs.
Quality Assurance Engineer
Sysnett Technology Solutions Pvt Ltd
Hyderabad
06.2006 - 02.2017
- Answered, screened, and processed over 200 calls daily using a call management system.
Conducted thorough research online to identify areas for service improvement.
Evaluated call-taking procedures to enhance customer service standards.
Maintained up-to-date knowledge of policies and procedures for efficient operations.
Education
Bachelor of Technology - Computer Science & Engineering
Jawaharlal Nehru Technological University
HyderabadSkills
- EU MDR: PMS and PMCF
- Post-market surveillance reports (PSUR)
- Safety and clinical evaluation
- FDA regulations: 21 CFR 820, 803, 806
- Global vigilance reporting
- Complaint handling and investigations
- Corrective and preventive actions (CAPA)
- Non-conformance management
- Root cause analysis
- Risk management strategies
- ISO 14971 compliance
- ISO 13485 quality management systems
- Audit and inspection readiness
- Cross-functional leadership
- Global stakeholder engagement
- Design remediation processes
- Design history file review
- Trend analysis techniques
- Signal detection methodologies
Certification
- FDA - MDR Awareness Training
- Good Documentation Practices (GDP)
- Internal Auditor (ISO 13485)
Tools And Systems
- TrackWise
- SmartSolve
- Wizard Tool
- Microsoft Office (Advanced Excel, Word, PowerPoint)
Languages
- English
- Hindi
- Telugu
Personal Information
Nationality: Indian
Current Location: Hyderabad, India
Languages: English, Hindi, Telugu
Willingness to Relocate: Open to global opportunities
Leadership And Influence
- Cross-functional collaboration across Quality, RA, R&D, Manufacturing, and Clinical
- Informal mentoring and knowledge sharing in complaint handling and vigilance processes
- Contributor to process enhancements, compliance consistency, and audit readiness
- Trusted quality voice in regulator-facing activities
Core Leadership And Technical Expertise
- EU MDR: PMS, PMCF, PSUR, SSCP
- FDA Regulations: 21 CFR 820, 803, 806
- Global Vigilance Reporting (FDA, EU)
- Complaint Handling & Investigations (End-to-End)
- CAPA, NC Management & Root Cause Analysis
- Risk Management (ISO 14971)
- ISO 13485 Quality Management Systems
- Audit & Inspection Readiness (Internal & External)
- Cross-Functional & Global Stakeholder Leadership
- Design Remediation & Design History Review
- Trend Analysis & Signal Detection
Languages
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Telugu
Native
Native
Timeline
MDR Vigilance Specialist
Medtronic
02.2023 - Current
Quality & Compliance Engagement
Encora Innovation Labs (Client: Wells Fargo)
02.2022 - 02.2023
Senior Associate
Tech Mahindra Ltd
10.2020 - 02.2022
Customer Service Engineer / Process Associate
Sysnett Technology Solutions | Janaspandana Software Solutions
03.2018 - 10.2020
Customer Quality Specialist (Google client)
Genpact
02.2017 - 03.2018
Quality Assurance Engineer
Sysnett Technology Solutions Pvt Ltd
06.2006 - 02.2017
Bachelor of Technology - Computer Science & Engineering
Jawaharlal Nehru Technological University