Regulatory IT Lead: Veeva RIM & CSV Expert

Vantive; Jalisco; Remote; MXN 600,000 - 1,000,000; Full time

Job summary

Vantive in Mexico is seeking a Regulatory IT Analyst to own and manage Quality & Regulatory IT applications, ensuring they meet GxP, 21 CFR Part 11, and CSV standards.

You will gather requirements, design solutions in Veeva, TrackWise, LabVantage LIMS, and coordinate validation, testing, and vendor collaboration.

Join a team focused on transforming vital organ therapies with digital solutions and ensure compliance throughout the system lifecycle.

Qualifications

• Experience gathering and documenting regulatory IT requirements.
• Knowledge of GxP, 21 CFR Part 11, and CSV principles.
• Ability to translate business needs into functional specifications.

Responsibilities

• Own regulatory IT applications and ensure design, operation, and maintenance.
• Lead system validation, testing, and change management in a regulated setting.
• Coordinate with IT, QA, Regulatory, and vendors for system support.
• Maintain system documentation and validated state across the lifecycle.
• Provide training and support to users for new implementations.

Skills

Regulatory IT

Business Analysis

System Validation

Testing & UAT

Vendor Collaboration

Tools

Veeva

TrackWise

LabVantage LIMS

Job description

Vantive in Mexico is seeking a Regulatory IT Analyst to own and manage Quality & Regulatory IT applications, ensuring they meet GxP, 21 CFR Part 11, and CSV standards.

You will gather requirements, design solutions in Veeva, TrackWise, LabVantage LIMS, and coordinate validation, testing, and vendor collaboration.

Join a team focused on transforming vital organ therapies with digital solutions and ensure compliance throughout the system lifecycle.