Senior IT Business Analyst, Regulatory Systems

Medtronic plc; Bogotá; Híbrido; COP 90.000.000 - 130.000.000; Jornada completa

Descripción de la vacante

Medtronic plc in Bogotá seeks a senior Principal IT Business Analyst to own the Regulatory IT eManuals platform, ensuring validation, audit readiness, and alignment with FDA, ISO13485, and EU MDR requirements. You will gather requirements, write specifications, and partner with global business and IT stakeholders.

This role offers a flexible working model and opportunities to shape regulatory systems across regions, driving compliant releases and documentation for internal and external audits.

Formación

• Bachelor’s degree in computer science, Information Technology, or related.
• Eight years’ experience as an IT Business Analyst or similar role.
• Fluent in English.
• In-depth knowledge of Software Validation Life Cycle Methodology.
• Understanding of the MedTech Regulatory industry.
• Excellent English communication and collaboration with global teams.

Responsabilidades

• Consult with business stakeholders to understand processes and identify needs; translate into system requirements.
• Write functional specifications and support development teams during implementation with testing and documentation.
• Deploy new and current systems, processes, and procedures cost-effectively.
• Configure settings, plan tests, and lead cross-functional teams for Regulatory Affairs applications.
• Maintain validation documentation per MSCM and regulatory standards (FDA, ISO13485, EU MDR).
• Ensure information protection across Medtronic systems.

Conocimientos

Fluent English

Excellent communication

Stakeholder management

Self-starter

Educación

Bachelor’s degree in computer science or IT

Descripción del empleo

Medtronic plc in Bogotá seeks a senior Principal IT Business Analyst to own the Regulatory IT eManuals platform, ensuring validation, audit readiness, and alignment with FDA, ISO13485, and EU MDR requirements. You will gather requirements, write specifications, and partner with global business and IT stakeholders.

This role offers a flexible working model and opportunities to shape regulatory systems across regions, driving compliant releases and documentation for internal and external audits.