Job DescriptionKey Skills: ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations
nRoles & Responsibilities:
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- Support post-production risk review activities as per defined regulatory schedulesn
- Coordinate with stakeholders to collect and analyze post-production data for risk assessmentn
- Prepare and update risk management reports and ensure approval workflow compliancen
- Maintain traceability matrices linking design requirements to objective evidencen
- Assist design control engineers in documentation and data analysis tasksn
- Query internal/external databases and generate reports for R&D; and risk teamsn
- Ensure documentation compliance with medical device regulatory standardsn
- Support lifecycle documentation across design, development, and post-production phasesn

nExperience Required:
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- 3-5 years of experience in medical device R&D;, risk management, or design control processesn
- Experience working in regulated environments (medical device or healthcare products)n
- Exposure to post-production risk analysis and reporting activitiesn
- Experience maintaining traceability matrices and design documentationn
- Experience working with cross-functional R&D; and quality/regulatory teamsn
- Experience supporting ISO 13485 / ISO 14971 compliance activitiesn
- Experience in data analysis and reporting for engineering/R&D; functionsn
- Exposure to IEC 62304 or similar medical software lifecycle standards is preferredn
- Experience working with requirement management or documentation tools is an advantagen

nEducation: Any Graduation

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