Senior IT BA, Global Regulatory Systems & eManuals

Partners in Digital Health; Bogotá; Híbrido; COP 120.000.000 - 180.000.000; Jornada completa

Descripción de la vacante

Medtronic, a global leader in healthcare technology, seeks a senior IT Business Analyst to own regulatory IT applications. You will help deliver eManuals platform enhancements, gather requirements, write functional specs, and collaborate with global stakeholders to ensure compliance and validation across audits.

A flexible working model is available. Ideal candidates have a strong background in requirements gathering, experience in regulated software validation, and excellent English

Formación

• Bachelor's degree in computer science, information technology, or related field.
• Eight years' experience as an IT Business Analyst, IT Technical Analyst, or software implementation project member.
• Fluent in English; strong communication skills.

Responsabilidades

• Consult with business stakeholders to understand and evaluate current processes and identify complex problems.
• Write system functional specifications and support development teams during implementation with testing and documentation.
• Deploy systems and processes in a cost-effective manner; ensure validation documents per MSCM and regulatory standards.
• Configure system settings and lead tests; coordinate cross-functional teams to address enhancements in Regulatory Affairs domain.
• Maintain documentation and ensure compliance with FDA 21 CFR, ISO13485, and EU MDR.

Conocimientos

Fluent English

Educación

Bachelor's degree in Computer Science or IT

Descripción del empleo

Medtronic, a global leader in healthcare technology, seeks a senior IT Business Analyst to own regulatory IT applications. You will help deliver eManuals platform enhancements, gather requirements, write functional specs, and collaborate with global stakeholders to ensure compliance and validation across audits.

A flexible working model is available. Ideal candidates have a strong background in requirements gathering, experience in regulated software validation, and excellent English