Risk Management Specialist (Medical Devices)

Staffing Services; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Staffing Services in Pune, India seeks a Medical Device Risk Manager to develop and maintain risk management plans and frameworks per ISO 14971 and FDA/IEC requirements, driving risk analysis and mitigation across the product lifecycle.

You will collaborate with design, regulatory, and quality teams, produce audit-ready documentation, and ensure compliance with IEC 60601, ISO 13485, and FDA QSR. 4–5 years of risk management experience preferred.

Qualifications

• Strong knowledge of ISO 14971, IEC 60601, ISO 13485 and FDA QSR requirements.
• Experience in risk management for medical devices across product lifecycle.
• Audit-ready documentation and traceability practices.

Responsibilities

• Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971.
• Lead risk analysis and mitigation activities including DFMEA and UFMEA across devices.
• Collaborate with design, regulatory, clinical, and quality teams to assess and mitigate risks.
• Provide risk input during design reviews and change control boards.
• Create and maintain risk files, traceability matrices, and risk-benefit analyses.

Skills

Regulatory understanding

Risk management

Documentation

Cross-functional collaboration

Education

MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, Systems Engineering

Tools

IBM DOORS

Windchill

Job description

• 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.
• MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, Systems Engineering, or related field. 610 years of experience in medical device development, with at least 4-5 years focused on risk management.
• Strong understanding of ISO 14971, IEC 60601, ISO 13485, and FDA Quality System requirements
• Experience with electromechanical systems and respiratory therapy devices is highly preferred.
• Strong analytical, documentation, and communication skills.