Key Skills: ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations
Roles & Responsibilities:
Support post-production risk review activities as per defined regulatory schedules
Coordinate with stakeholders to collect and analyze post-production data for risk assessment
Prepare and update risk management reports and ensure approval workflow compliance
Maintain traceability matrices linking design requirements to objective evidence
Assist design control engineers in documentation and data analysis tasks
Query internal/external databases and generate reports for R&D; and risk teams
Ensure documentation compliance with medical device regulatory standards
Support lifecycle documentation across design, development, and post-production phases
Experience Required:
3-5 years of experience in medical device R&D;,



risk management, or design control processes
Experience working in regulated environments (medical device or healthcare products)
Exposure to post-production risk analysis and reporting activities
Experience maintaining traceability matrices and design documentation
Experience working with cross-functional R&D; and quality/regulatory teams
Experience supporting ISO 13485 / ISO 14971 compliance activities
Experience in data analysis and reporting for engineering/R&D; functions
Exposure to IEC 62304 or similar medical software lifecycle standards is preferred
Experience working with requirement management or documentation tools is an advantage
Education: Any Graduation

📌 Medical Device R&D Process (Bengaluru)
🏢 MyCareernet
📍 Bengaluru