Validation & Verification SME

Katalyst CRO; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking an experienced Validation & Verification (V&V) SME to lead end-to-end validation activities for complex medical systems in a regulated U.S. setting.

The role covers protocol authoring, execution, reporting, and compliance management with IQ/OQ/PQ, CSV, and system validation. The ideal candidate will guide risk-based validation approaches and collaborate with R&D, Quality, Manufacturing, and Regulatory teams while supporting audit readiness and regulatory inspections.

Qualifications

• 812+ years of Medical Device V&V experience.
• Proven SME in validation strategies and risk-based validation.

Responsibilities

• Lead end-to-end validation activities, including protocol authoring, execution, reporting, and compliance management for complex medical systems.
• Author, review, and execute validation protocols including IQ, OQ, PQ, CSV, and System Validation.
• Manage the complete validation lifecycle with test execution, documentation, defect tracking, and reporting.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support validation activities.
• Provide SME guidance on validation strategies and risk-based validation approaches.
• Support audit readiness, regulatory inspections, and documentation reviews.
• Drive multiple validation protocols simultaneously in a fast-paced environment.
• Familiarity with TrackWise, Veeva, ETQ, or equivalent QA tools.

Skills

V&V Expertise

IQ/OQ/PQ

CSV

FDA 21 CFR Part 820

ISO 13485

ISO 14971

Regulated Environment

Audit Readiness

Documentation

Stakeholder Management

Imaging/Surgical Systems

Onsite US Client Engagement

TrackWise/Veeva/ETQ

Tools

TrackWise

Veeva

ETQ

Job description

• We are seeking an experienced Validation & Verification (V&V) SME with 812+ years of experience in the Medical Device industry.
• The ideal candidate will independently lead end-to-end validation activities, including protocol authoring, execution, reporting, and compliance management for complex medical systems in a regulated environment.
• Author, review, and execute validation protocols including IQ, OQ, PQ, System Validation, and CSV.
• Manage the complete validation lifecycle, including test execution, documentation, defect tracking, and reporting.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support validation activities.
• Provide SME-level guidance on validation strategies and risk-based validation approaches.
• Support audit readiness, regulatory inspections, and documentation reviews.
• Drive multiple validation protocols simultaneously in a fast-paced environment.
• Strong expertise in Medical Device Validation & Verification (V&V).
• Hands-on experience with IQ/OQ/PQ, Computerized System Validation (CSV), and System Validation.
• Deep understanding of FDA regulations, ISO 13485, and ISO 14971 Risk Management.
• Experience working in highly regulated environments with minimal supervision.
• Excellent documentation, communication, and stakeholder management skills.
• Experience with complex medical systems such as imaging, surgical, or similar platforms.
• Familiarity with QMS tools such as TrackWise, Veeva, ETQ, or equivalent.
• Experience supporting large-scale validation programs with 100+ protocols.
• Prior onsite client engagement experience in the United States.

Job Summary

• We are seeking an experienced Validation & Verification (V&V) SME with 812+ years of experience in the Medical Device industry.
• The ideal candidate will independently lead end-to-end validation activities, including protocol authoring, execution, reporting, and compliance management for complex medical systems in a regulated environment.
• Author, review, and execute validation protocols including IQ, OQ, PQ, System Validation, and CSV.
• Manage the complete validation lifecycle, including test execution, documentation, defect tracking, and reporting.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support validation activities.
• Provide SME-level guidance on validation strategies and risk-based validation approaches.
• Support audit readiness, regulatory inspections, and documentation reviews.
• Drive multiple validation protocols simultaneously in a fast-paced environment.
• Strong expertise in Medical Device Validation & Verification (V&V).
• Hands-on experience with IQ/OQ/PQ, Computerized System Validation (CSV), and System Validation.
• Deep understanding of FDA regulations, ISO 13485, and ISO 14971 Risk Management.
• Experience working in highly regulated environments with minimal supervision.
• Excellent documentation, communication, and stakeholder management skills.
• Experience with complex medical systems such as imaging, surgical, or similar platforms.
• Familiarity with QMS tools such as TrackWise, Veeva, ETQ, or equivalent.
• Experience supporting large-scale validation programs with 100+ protocols.
• Prior onsite client engagement experience in the United States.

Roles & Responsibilities

• Author, review, and execute validation protocols including IQ, OQ, PQ, System Validation, and CSV.
• Manage the complete validation lifecycle, including test execution, documentation, defect tracking, and reporting.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 standards.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to support validation activities.
• Provide SME-level guidance on validation strategies and risk-based validation approaches.
• Support audit readiness, regulatory inspections, and documentation reviews.
• Drive multiple validation protocols simultaneously in a fast-paced environment.
• Strong expertise in Medical Device Validation & Verification (V&V).
• Hands-on experience with IQ/OQ/PQ, Computerized System Validation (CSV), and System Validation.
• Deep understanding of FDA regulations, ISO 13485, and ISO 14971 Risk Management.
• Experience working in highly regulated environments with minimal supervision.
• Excellent documentation, communication, and stakeholder management skills.
• Experience with complex medical systems such as imaging, surgical, or similar platforms.
• Familiarity with QMS tools such as TrackWise, Veeva, ETQ, or equivalent.
• Experience supporting large-scale validation programs with 100+ protocols.
• Prior onsite client engagement experience in the United States.

Experience:

• 812+ years of Medical Device V&V experience.
• Proven track record as a Validation Subject Matter Expert (SME).
• Ability to work independently, manage priorities, and deliver under tight timelines.