Role: Risk Management File SME
Location: Remote EST

Summary:
Senior level (7 10+ yrs). Focuses specifically on assessing and remediating the overall Risk Management File. Must have deep experience building and maintaining complete risk management files for complex medical devices.

Key Responsibilities

• Assess and remediate the overall Risk Management File for the device
• Ensure the risk management file is complete, consistent, and compliant with ISO 14971
• Identify and close gaps in risk documentation across all phases
• Integrate risk outputs from all workstreams into a cohesive risk management file
• Collaborate with Risk COE and all workstream leads

Required Qualifications

• Senior medical device risk management experience - 7 10+ yrs preferred
• Deep expertise in ISO 14971 and FDA QMSR risk management requirements
• Experience building or remediating complete risk management files
• Experience across multiple design control phases with risk integration
• Experience in remediation initiatives in regulated environments

Thanks &