Validation & Verification Risk SME

Intellectt INCArizona 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 Validation & Verification Risk 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: Validation &Verification Risk SME Location: Remote (EST)

Summary: Mid-to-senior level (5 8+ yrs). Focused on risk within Verification and Validation activities. Reviews Validation & Verfication documentation through a risk lens and ensures risk is appropriately integrated into testing strategies.

Key Responsibilities

Provide risk expertise specific to Validation & Verfication documentation and activities
Review verification and validation documentation for appropriate risk consideration
Support retrospective risk evaluation within Validation & Verfication documentation
Assist in development of risk-based justifications for Validation & Verfication gaps
Collaborate with Validation & Verfication workstream leads and Risk COE

Required Qualifications

Medical device risk management experience with focus on Validation & Verfication
Familiarity with ISO 14971 and QMSR risk expectations
Experience reviewing Validation & Verfication documentation with risk considerations
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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