Risk Management Specialist

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Roles and Responsibilities :

• Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971.
• Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements.
• Lead comprehensive risk analysis and mitigation for
• Hazard identification
• Design FMEA (dFMEA)
• Use FMEA (uFMEA)
• Product risk analysis and control
• Integrate risk controls into the design and development process to ensure safety and compliance.
• Collaborate with design, clinical, regulatory, and quality teams to assess and mitigate risks throughout the product lifecycle.
• Provide risk-related input during design reviews, change control boards, and technical discussions.
• Create and maintain risk files, traceability matrices, and risk-benefit analyses.
• Ensure compliance with IEC 60601, ISO 80601 and ISO 14971 standards for electromechanical and respiratory devices.
• Maintain clear, audit-ready documentation of risk assessments and mitigation strategies.
• Participate in internal and external audits, representing risk management documentation and processes.
• Experience with requirements and traceability tools such as IBM DOORS and Windchill.

Education & Skills preferred :

Skills Required

Iso 14971, Iso 13485, Fmea, iec 60601 , Dfmea, Windchill