Risk Management File SME

Intellectt INCbullhead city, AZ

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Job Description

Hello,

I hope you're doing well.

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Risk Management File SME based in Remote (EST) with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at

vyshnavi.t@intellectt.com

Role: Risk Management File SMELocation: 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 & Regards,• Vyshnavi Thuraka• Recruiter• Intellectt Inc • vyshnavi.t@intellectt.com• Direct: 732 204 6550• Desk number: 732 412 6999 - Ext: 225

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