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 As the Sr Specialist, IT RA Global Apps, you will:
- 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.
- Assist with project management tasks, ensuring timely delivery of IT solutions. 6. Technical Skills & Experience
- The adecuado candidate should have a strong technical foundation with hands-on experience in enterprise application support, configuration, and deployment. Key technical competencies include:
- Programming & Scripting: Basic understanding of Java, .
NET, and SQL, with the ability to analyze and troubleshoot application logic, scripts, and database queries.
- Cloud & Infrastructure: Knowledge of AWS or Azure, including experience with deploying, configuring, and maintaining applications in a cloud environment.
- Validation & Compliance: Experience working in a regulated life science environment with understanding of CSV (Computer System Validation) and GxP requirements, including writing and executing IQ/OQ/PQ scripts
- Cloud Computing and Data Management: Familiarity with SaaS environments (e.g., Veeva Vault Platform, Salesforce-based systems), including workflows, lifecycles, and user permissions.
- Regulatory Domain: Hands-on experience with platforms like Veeva Vault QMS, TrackWise Digital. Understanding of regulatory process and submissions, including submission registration and publishing, promotiona

📌 Senior IT Specialist, Regulatory Systems (Guadalajara)
🏢 Vantive
📍 Guadalajara