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 transparent, 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.

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