Senior IT Specialist, Regulatory Systems – Veeva RIM

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Take ownership and manage Regulatory applications in line with business needs.

• Function as a business analyst by collecting and analyzing requirements, defining specifications, and designing solutions.

• Lead system validation, testing execution, and change management within a regulated framework.

• Supervise system upkeep, upgrades, defect tracking, and resolution of issues.

• Act as a liaison among IT, business process stakeholders, and external vendors.

• Ensure adherence to GxP, 21 CFR Part 11, CSV, FDA, ISO 13485, and global regulatory standards.

• Maintain functional requirements, design specifications, validation plans, and change-control documentation.

• Convert business requirements into functional and technical specifications.

• Create and implement configurable solutions in Veeva, TrackWise, LabVantage LIMS, and other Quality/Regulatory applications.

• Develop and execute test scripts, UAT scenarios, and validation plans.

• Manage risk assessments, audits, and regulatory inspections related to system validation.

• Oversee upgrades, patches, maintenance, issue triage, root-cause analysis, and defect resolution.

• Support global Quality and Regulatory IT projects and initiatives for digital transformation.

• Provide training and support to end users.

• Assist with project management and coordinate system upgrades, implementations, and process enhancements.

⛳️ Requirements

• Bachelor’s degree in Computer Science, Information Systems, or a related discipline.

• Over 3 years of experience in IT business analysis, system ownership, or validation within the Life Sciences, Pharmaceutical, or Medical Device sectors.

• Practical experience with Veeva, TrackWise, or other Regulatory/Quality applications.

• In-depth knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), and compliance with regulatory standards.

• Capability to develop and execute test scripts, validation plans, and system documentation.

• Technical expertise in SQL, system integrations, and application configuration.

• Basic familiarity with Java, .NET, and SQL.

• Knowledge of AWS or Azure, including cloud application deployment, configuration, and maintenance.

• Experience with CSV, GxP requirements, and the preparation and execution of IQ/OQ/PQ scripts.

• Familiarity with SaaS environments such as Veeva Vault Platform and Salesforce-based systems.

• Hands-on experience with Veeva Vault QMS or TrackWise Digital.

• Understanding of regulatory processes and submissions, including registration and publishing.

• Proficiency in both Spanish and English, both spoken and written, is required.

• Ability to analyze intricate business requirements and align them with system capabilities.

• Problem-solving skills to troubleshoot system issues while ensuring compliance.

• Strong verbal and written communication abilities for interactions with IT, QA, regulatory affairs, and business stakeholders.

• Meticulous attention to detail when documenting system changes, validation protocols, and SOPs.

• Preferred: experience with Veeva, Salesforce, AWS, Azure, or cloud-based environments.

• Preferred: basic project management experience utilizing Agile, Waterfall, or hybrid methodologies.

🏝️ Benefits

• Remote position available.

• Reasonable accommodations provided for individuals with disabilities.

• Opportunities for growth and development to further your career.