Senior It Specialist, Regulatory Systems (Veeva Rim) | Remote

Vantive; Jalisco; A distancia; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory IT

Business Analysis

System Validation

Testing & UAT

Vendor Collaboration

Herramientas

Veeva

TrackWise

LabVantage LIMS

Descripción del empleo

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients - that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role

• Own and manage Regulatory applications, ensuring they are designed, operated, and maintained per business requirements.
• Serve as the functional business analyst, gathering and analyzing business needs, defining requirements, and architecting solutions.
• Lead system validation, testing execution, and change management in a regulated environment.
• Oversee system maintenance, upgrades, defect tracking, and issue resolution in collaboration with IT and business teams.
• Act as the primary liaison between IT, business process owners, and external vendors.

What you'll be doing

1. System Ownership & Governance

• Serve as the primary system owner for Quality & Regulatory IT applications, ensuring compliance with GxP, 21 CFR Part 11, and Computer System Validation (CSV) requirements.
• Implement solutions that align with business needs and regulatory requirements.
• Maintain system documentation, including functional requirements, design specifications, validation plans, and change control records.
• Ensure systems remain in a validated state throughout their lifecycle.

2. Functional Business Analysis & Solution Design

• Gather, analyze, and document business requirements, workflows, and process improvements.
• Translate business needs into functional and technical specifications.
• Collaborate with IT teams to develop and deploy configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.
• Ensure solutions are scalable, compliant, and aligned with Vantive’s digital transformation strategy.

3. Validation, Testing & Compliance

• Lead Computer System Validation (CSV) efforts, ensuring applications meet FDA, ISO 13485, and global regulatory standards.
• Develop and execute test scripts, UAT scenarios, and validation plans for new implementations and system changes.
• Manage risk assessments, audits, and regulatory inspections related to system validation and compliance.

4. System Maintenance, Enhancements & Issue Resolution

• Oversee system upgrades, patches, and maintenance, recommending enhancements as needed.
• Manage issue triage, root cause analysis, and resolution for system defects.
• Work closely with business process owners to ensure applications align with operational needs.
• Coordinate with vendors and internal teams for system support and enhancements.

5. Stakeholder Collaboration & Project Support

• Act as a key liaison between IT, Quality, Regulatory, and business stakeholders.
• Support global Quality and Regulatory IT projects, including new system implementations and digital transformation initiatives.
• Provide end-user training and support, ensuring smooth adoption of system enhancements.