Website:
mycareernet.co
Job details:
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
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