Opening For MNC Co Risk Management Pune

Staffing Services; Pune District; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Staffing Services seeks a risk management professional to develop and maintain risk management plans for medical devices, ensuring compliance with ISO 14971, ISO 13485, IEC 60601 and FDA requirements. You will lead hazard analysis, FMEA activities (design and use), integrate risk controls into design, and collaborate across design, regulatory, clinical, and quality teams.

Responsibilities include creating risk files, traceability matrices, risk-benefit analyses, and maintaining audit-ready

Competenze

• Experience implementing ISO 14971 risk management processes for medical devices.
• Knowledge of FDA 21 CFR Part 820.30 and ISO 13485 design controls.
• Familiarity with design reviews and risk-based decision making.
• Exposure to hazard analysis and FMEA (design and use) methodologies.
• Experience with risk documentation and traceability tooling (e.g., DOORS, Windchill).

Mansioni

• Develop and maintain risk management plans, procedures, and frameworks aligned with ISO 14971.
• Ensure risk activities meet FDA 21 CFR Part 820.30 and ISO 13485 design controls.
• Lead risk analysis and mitigation including hazard identification, dFMEA, and uFMEA.
• Integrate risk controls into design and development to ensure safety and compliance.
• Collaborate with design, clinical, regulatory, and quality teams to mitigate risks through the product lifecycle.
• Provide risk input during design reviews, change control boards, and technical discussions.
• Create and maintain risk files, traceability matrices, and risk-benefit analyses.
• Ensure IEC 60601, ISO 80601 and ISO 14971 compliance for electromechanical and respiratory devices.
• Maintain audit-ready risk assessment documentation and mitigation strategies.
• Participate in internal/external audits, representing risk management processes.
• Experience with IBM DOORS and Windchill.

Descrizione del lavoro

Role & 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.