Job Description

Key Skills: ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations

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Roles & Responsibilities:

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- Support post-production risk review activities as per defined regulatory schedules
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- Coordinate with stakeholders to collect and analyze post-production data for risk assessment
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- Prepare and update risk management reports and ensure approval workflow compliance
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- Maintain traceability matrices linking design requirements to objective evidence
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- Assist design control engineers in documentation and data analysis tasks
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- Query internal/external databases and generate reports for R&D; and risk teams
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- Ensure documentation compliance with medical device regulatory standards
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- Support lifecycle documentation across design, development, and post-production phases
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Experience Required:

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- 3-5 years of experience in medical device R&D;, risk management, or design control processes
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- Experience working in regulated environments (medical device or healthcare products)
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- Exposure to post-production risk analysis and reporting activities
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- Experience maintaining traceability matrices and design documentation
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- Experience working with cross-functional R&D; and quality/regulatory teams
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- Experience supporting ISO 13485 / ISO 14971 compliance activities
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- Experience in data analysis and reporting for engineering/R&D; functions
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- Exposure to IEC 62304 or similar medical software lifecycle standards is preferred
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- Experience working with requirement management or documentation tools is an advantage
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Education: Any Graduation

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