Krishna Mohan
@krishnamohan1
Medical device vigilance specialist at MiniMed, leading FDA and EU MDR compliance and strengthening complaint handling.
IndiaWhat I'm looking for
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
Work history, roles, and key accomplishments
MDR Vigilance Specialist
MiniMed
Mar 2026 - Present (8 months)
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.
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.
Quality & Compliance Engagement
Encora Innovation Labs
Feb 2022 - Feb 2023 (1 year)
Delivered quality and documentation support within regulated electronic systems, including SmartSolve and Wizard tools. Ensured accuracy, compliance, and traceability of documentation in controlled environments.
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
Mar 2018 - Oct 2020 (2 years 7 months)
Established robust foundations in process discipline, documentation, and customer-oriented problem solving, later utilized in regulated quality environments.
Customer Service Engineer / Process Associate
Janaspandana Software Solutions
Mar 2018 - Oct 2020 (2 years 7 months)
Established robust foundations in process discipline, documentation, and customer-oriented problem solving, later utilized in regulated quality environments.
Managed end-to-end complaint handling, including intake, investigation, categorization, and closure. Determined safety impact and reportability, creating reportable and nonreportable investigation tasks.
Quality Assurance Engineer
Sysnett Technology Solutions
Jun 2006 - Feb 2017 (10 years 8 months)
Answered, screened, and processed over 200 calls daily using a call management system. Conducted thorough research online to identify areas for service improvement.
Education
Degrees, certifications, and relevant coursework
Jawaharlal Nehru Technological University, Hyderabad
Bachelor of Technology, Computer Science & Engineering
Bachelor of Technology in Computer Science & Engineering from Jawaharlal Nehru Technological University, Hyderabad.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Salary expectations
Social media
Job categories
Skills
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