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

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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

/n /n Experience Required: /n /n

- 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

/n /n Education: Any Graduation

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