Medical Device Validation and Verification SME

Medical Device Validation and Verification SME

Location: San Diego, CA

Duration: 6 months

Preferred Skills

· Experience with complex medical systems (e.g., imaging systems, surgical systems, or similar platforms like Elita)

· Exposure to software validation / computerized system validation (CSV)

· Prior experience in large-scale validation programs (100+ protocols)

· Strong documentation and audit readiness experience

· Familiarity with tools like: o TrackWise / Veeva / ETQ (or similar QMS systems) Experience Requirement

· 8–12+ years in V&V within the medical device industry

· Proven experience working as a Subject Matter Expert (SME)

· Prior experience working in onsite client environments in the US is a strong plus

· Expat profiles are acceptable Candidate Profile

· Self-driven and capable of working independently with minimal guidance

· Strong ownership mindset with execution focus

· Excellent communication and stakeholder management skills

· Comfortable working under tight timelines and immediate onboarding expectations

Roles & Responsibilities

Role Overview:

We are looking for experienced Validation & Verification (V&V) experts to support protocol development and execution for the Elita system. The role requires independent ownership of end-to-end V&V activities with minimal onboarding or training. The candidate will contribute toward executing approximately 150–170 validation protocols within a defined timeline

Key Responsibilities:

· Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system validation, software validation, etc.)

· Ensure all validation activities comply with regulatory standards (FDA, ISO 13485, 21CFR Part 820)

· Drive end-to-end protocol lifecycle, including:

o   Protocol authoring

o   Test execution

o   Documentation and reporting

o   Defect tracking and resolution

· Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory)

· Provide SME-level inputs for validation strategy and risk-based validation approaches

· Support audit readiness and documentation for regulatory inspections

· Work in a high-paced environment with immediate delivery expectations

Generic Managerial Skills, If any

1. Leadership

2. Communication Skills

3. Stakeholder Management

4. Decision Making

5. Problem Solving

6. Mentoring & Coaching

7. Conflict Resolution

8. Strategic Thinking

9. Time & Priority Management

10. Adaptability & Flexibility

Desirable Skills:

Keyword: Skills: ISO 13485~EIS : Medical Device & Regulations