# Krishna Mohan Krishna Mohan is a remote worker on Himalayas, MDR Vigilance Specialist at MiniMed, based in India. Source: https://himalayas.app/@krishnamohan1 ```text Medical device vigilance specialist at MiniMed, leading FDA and EU MDR compliance and strengthening complaint handling. ``` | Detail | Value | | --- | --- | | Availability | Looking for a job | | Location | India | | Authorized to work in | India | | Salary expectations | 140k+ INR | | Job categories | Medical Device Vigilance Specialist, Quality Assurance Engineer, Quality Compliance Specialist, Post Market Surveillance Specialist | | Skills | Device Vigilance, FDA Regulations, EU MDR, Post Market Surveillance, Post Market Clinical Follow Up, Periodic Safety Update Reports (PSURs), Complaint Handling, Complaint Investigation, Vigilance Reporting, Reportability Assessments, Risk Management, ISO 14971, CAPA, Non Conformance Management, Root Cause Analysis | | LinkedIn | https://www.linkedin.com/in/krishna-mohan-t-v-6892106a | ## What I'm looking for ```text I’m open to global opportunities and willing to relocate. ``` ## About ```text At MiniMed (formerly Medtronic), I lead FDA and EU MDR vigilance and ensure complaint management meets regulatory requirements. I conduct risk and reportability assessments, review ISO 14971 risk management files, and author investigation summaries based on technical product analysis. I’ve supported global vigilance reporting and submissions, and worked with R&D, Regulatory Affairs, Manufacturing, and Clinical teams to strengthen complaint handling and inspection readiness. At Genpact, I managed end-to-end complaint handling for a Google client, including safety impact and reportability assessments, and maintained records in TrackWise. My work spans post-market surveillance, complaint investigations, CAPA, and quality systems in the medical device industry. I’ve also supported documentation and traceability in regulated electronic systems at Encora Innovation Labs, for its Wells Fargo client. ``` ## Experience ### MDR Vigilance Specialist (current) MiniMed. Mar 2026 - Present ```text 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. ``` Skills: FDA-Regulations, EU-MDR, Complaint-Handling, Risk-Management, ISO-14971, CAPA, 21-CFR-820, CFR-803, Vigilance-Reporting, Investigation, Regulatory-Compliance ### MDR Vigilance Specialist [Medtronic](https://himalayas.app/companies/medtronic). Feb 2023 - Feb 2026 ```text 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. ``` Skills: FDA-Regulations, EU-MDR, Complaint-Handling, Risk-Management, ISO-14971, CAPA, 21-CFR-820, CFR-803, Vigilance-Reporting, Investigation, Regulatory-Compliance ### Quality & Compliance Engagement Encora Innovation Labs. Feb 2022 - Feb 2023 ```text Delivered quality and documentation support within regulated electronic systems, including SmartSolve and Wizard tools. Ensured accuracy, compliance, and traceability of documentation in controlled environments. ``` Skills: SmartSolve, Wizard-Tool, Documentation, Compliance, Quality-Assurance ### Senior Associate [Tech Mahindra](https://himalayas.app/companies/tech-mahindra). Oct 2020 - Feb 2022 ```text Supported quality-driven customer operations with strong process adherence. Applied analytical decision-making to improve service outcomes and compliance. ``` Skills: Process-Adherence, Analytical-Skills, Customer-Operations, Quality-Assurance ### Customer Service Engineer / Process Associate Sysnett Technology Solutions. Mar 2018 - Oct 2020 ```text Established robust foundations in process discipline, documentation, and customer-oriented problem solving, later utilized in regulated quality environments. ``` Skills: Process-Discipline, Documentation, Customer-Service, Problem-Solving ### Customer Service Engineer / Process Associate Janaspandana Software Solutions. Mar 2018 - Oct 2020 ```text Established robust foundations in process discipline, documentation, and customer-oriented problem solving, later utilized in regulated quality environments. ``` Skills: Process-Discipline, Documentation, Customer-Service, Problem-Solving ### Customer Quality Specialist (Google Client) [Genpact](https://himalayas.app/companies/genpact). Feb 2017 - Mar 2018 ```text Managed end-to-end complaint handling, including intake, investigation, categorization, and closure. Determined safety impact and reportability, creating reportable and nonreportable investigation tasks. ``` Skills: Complaint-Handling, Investigation, Trackwise, Good-Documentation-Practices-(GDP), CAPA, Quality-Assurance ### Quality Assurance Engineer Sysnett Technology Solutions. Jun 2006 - Feb 2017 ```text Answered, screened, and processed over 200 calls daily using a call management system. Conducted thorough research online to identify areas for service improvement. ``` Skills: Call-management, Customer-Service, Research, Process-Improvement ## Education ### Jawaharlal Nehru Technological University, Hyderabad Bachelor of Technology, Computer Science & Engineering ```text Bachelor of Technology in Computer Science & Engineering from Jawaharlal Nehru Technological University, Hyderabad. ``` ## Tech stack - Microsoft Excel - Microsoft Word - Microsoft PowerPoint - Microsoft Office To contact Krishna, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire). ## People also viewed - [Avisek Charan](https://himalayas.app/@avisekcharan): Regulatory Affairs Executive, Vitromed Healthcare - [Yashmin Khatun](https://himalayas.app/@yashminkhatun): Senior Associate, Wipro - [Boopathy Mayilsamy](https://himalayas.app/@boopathymayilsamy): Regulatory Analyst – Post Market Surveillance, HCL Technologies - [Mohamed Shaik Ashik R](https://himalayas.app/@mohamedshaikashikr): Regulatory Compliance Specialist, HMS Medical Systems - [Amit Paul](https://himalayas.app/@amitpaul): Senior Quality Assurance Lead, GE Healthcare - [shagun punetha](https://himalayas.app/@shagunpunetha): Senior Executive – Product Surveillance, Baxter India Pvt. 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