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Validation & Verification SME
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
3 months ago
- Risk Management
- Veeva
3 months ago
Not enough detail in this posting to match
- We are seeking an experienced Validation & Verification (V&V) SME with 8–12+ 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.
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.
- 8–12+ 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.
Validation & Verification SME · Katalyst Healthcares & Life Sciences