Senior IT Specialist, Regulatory Systems (Veeva RIM) | Remote

Location: Remote across Mexico; location listed as Guadalajara, Jalisco

Company

hirify.global develops vital organ therapy solutions and digital services, with a focus on kidney care, dialysis, and other regulated medical therapies.

What you will do

• Own and govern Quality and Regulatory IT applications throughout their lifecycle, keeping them compliant and in a validated state.
• Gather business requirements, analyze workflows, define functional and technical specifications, and design configurable solutions.
• Lead system validation, testing, UAT, risk assessments, audits, and regulatory inspection support.
• Oversee upgrades, patches, maintenance, defect triage, root-cause analysis, issue resolution, and enhancements.
• Coordinate with IT, Quality, Regulatory, business stakeholders, developers, cloud teams, vendors, and process owners.
• Support global implementations and digital transformation projects, provide end-user training, and assist with project management.

Requirements

• Bachelor’s degree in Computer Science, Information Systems, or a related field.
• 3+ years of experience in IT business analysis, system ownership, or validation within the life sciences, pharmaceutical, or medical device industry.
• Hands-on experience with Veeva, TrackWise, or other Regulatory/Quality applications.
• Strong knowledge of GxP, 21 CFR Part 11, Computer System Validation (CSV), FDA, ISO 13485, and regulatory compliance.
• Ability to develop and execute test scripts, validation plans, IQ/OQ/PQ scripts, UAT scenarios, and system documentation.
• Technical knowledge of SQL, system integrations, application configuration, and enterprise application support.
• Basic understanding of Java and .NET, including application logic, scripts, and database query troubleshooting.
• Knowledge of AWS or Azure and experience deploying, configuring, and maintaining cloud applications.
• Familiarity with SaaS environments such as Veeva Vault Platform and Salesforce-based systems, including workflows, lifecycles, and user permissions.
• Understanding of regulatory processes and submissions, including submission registration and publishing, promotional materials, regulatory authorities, and global product registration.
• Strong analytical, problem-solving, communication, collaboration, and documentation skills.
• Spanish and English speaking and written communication skills are mandatory.

Nice to have

• Experience with Veeva, Salesforce, AWS, Azure, or other cloud-based environments.
• Basic project management experience using Agile, Waterfall, or hybrid methodologies.
• Experience coordinating system upgrades, implementations, or process improvements, including Veeva’s annual releases.

Culture & Benefits

• Remote position open to applicants across Mexico.
• Work on digital solutions and advanced services intended to improve patient and care-team outcomes.
• Collaborate across IT, Quality, Regulatory, business, vendor, developer, and cloud teams.
• Reasonable accommodations are available globally for qualified applicants with disabilities during the application and interview process.