Principle IT Business Analyst

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

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

As a key member of the Medtronic team, you will play an integral role in advancing healthcare technologies that make a meaningful difference in patients' lives. This position offers the opportunity to collaborate with talented professionals in a dynamic environment, supporting our mission to alleviate pain, restore health, and extend life. You will contribute to innovative projects, drive impactful solutions, and help shape the future of global healthcare.

We are seeking a senior-level experienced Principle IT Business Analyst to join our Regulatory Systems team which supports the Regulatory Affairs functions within all operating units and regions.

Primary focus of this position is the IT application ownership of the Medtronic eManuals platform, via which we globally provide electronic Instructions For Use in a digital fashion to Patients, Healthcare Professionals and Service Technicians.

Execution against the Regulatory IT roadmap to deliver maintenance- and enhancements releases, ensuring that the eManuals platform remains in a compliant, validated state, with the creation of corresponding documentation for both internal- and external audits are the key responsibilities.

The ideal candidate will have a strong background in requirements gathering, writing functional specifications as input for configuration and development efforts, is experienced working in a regulated industry in which strict software validation practices apply, and has experience with communicating with business and IT stakeholders on project status on a global level. This role will have a flexible working model.

Responsibilities may include the following and other duties may be assigned:

• Consults withbusiness 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

Required Knowledge and Experience:

• Bachelor's degree in computer science, Information Technology, or related
• 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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).