Principle IT Business Analyst
Medtronic · Bogota, Colombia
IT & SoftwareFull-timeCompany career page
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Role summary
Medtronic seeks a senior IT Business Analyst to manage the eManuals platform for the Regulatory Systems team. The role involves requirements gathering, functional specifications, system testing, and regulatory compliance documentation for a global digital Instructions For Use platform.
What they're looking for
- Bachelor's degree in computer science, information technology, or related field
- Eight years' experience as IT Business Analyst or IT Technical Analyst in MedTech
- Fluent in English with excellent communication and collaboration skills
- In-depth knowledge of Software Validation Life Cycle Methodology
- General understanding of MedTech regulatory industry and FDA/ISO standards
- Ability to work independently and effectively with global cross-functional teams
What you'll be doing
- Consult with business stakeholders to understand processes and translate needs into system requirements
- Write functional specifications and support development teams during testing and implementation
- Configure systems, plan and execute unit, system, and integration tests
- Maintain validation documentation and ensure compliance with FDA 21CFR, ISO13485, and EU MDR
- Protect systems and information according to Medtronic policies and best practices
Privacy & handoff
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