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



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

📌 Medical Device R&D Process & Product Design Associate_99765 (Bengaluru)
🏢 MyCareernet
📍 Bengaluru