Senior IT Business Analyst, Regulatory Systems

Medtronic; Bogotá ciudad; Híbrido; COP 280.260.000 - 404.820.000; Jornada completa

Descripción de la vacante

Medtronic is seeking a senior-level Principle IT Business Analyst to join the Regulatory Systems team supporting Regulatory Affairs globally. This role focuses on IT ownership of the eManuals platform to provide electronic Instructions for Use to patients and professionals, in a compliant, validated state.

The ideal candidate has extensive experience gathering requirements, writing functional specs for configuration and development, and communicating project status to global stakeholders in a

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 with a preferred focus on the MedTech Regulatory industry.
• Fluent in English
• In-depth knowledge of industry best practices and terminology related to the Software Validation Life Cycle Methodology.
• General understanding of the MedTech Regulatory industry.
• Excellent communication in English as well as collaboration skills, with the ability to work effectively with global cross-functional teams and business stakeholders.
• Ability to work effectively in a team environment and build strong working relationships.
• Self-starter able to establish relationships in a matrix environment.
• Ability to work with remote teams of professionals and able to work independently to achieve objectives.

Responsabilidades

• Consults with business stakeholders to understand and evaluate current business processes and identify complex business problems and needs, turning those needs into system requirements.
• Writing system functional specifications and support development teams during implementation phase with testing and quality documentation.
• Deploy new and current systems, processes, and procedures in a cost-effective manner.
• Configure system settings, plan, and execute unit-, system- and integration tests and lead cross-functional linked teams to address business or systems enhancements for applications within the Regulatory Affairs domain.
• Maintain relevant documentation and ensure proper validation documentation is created for all projects according MSCM (Medtronic Systems Compliance Methodology) and ensuring compliance with applicable regulations such as FDA 21CFR, ISO13485 and EU MDR.
• Ensure that Medtronic's systems and the information on them are protected in accordance with Medtronic's Information Protection Policies and Standards, as well as best Information Protection practices.

Conocimientos

Fluent English

Excellent communication

Cross-functional collaboration

Teamwork

Remote collaboration

Educación

Bachelor's degree in Computer Science / IT

Descripción del empleo

Medtronic is seeking a senior-level Principle IT Business Analyst to join the Regulatory Systems team supporting Regulatory Affairs globally. This role focuses on IT ownership of the eManuals platform to provide electronic Instructions for Use to patients and professionals, in a compliant, validated state.

The ideal candidate has extensive experience gathering requirements, writing functional specs for configuration and development, and communicating project status to global stakeholders in a