Sr Prin IT Technologist.

Medtronic; Bogotá ciudad; Presencial; COP 180.000.000 - 260.000.000; Jornada completa

Descripción de la vacante

Medtronic Bogotá seeks a senior-level Principle IT Business Analyst to join the Regulatory Systems team, owning the IT application for the eManuals platform and delivering compliant validation and documentation for audits.

You will gather requirements, write functional specs, support validation in FDA/ISO contexts, and collaborate with global stakeholders in a flexible work model.

Formación

• Bachelor’s degree in computer science, IT, or related.
• Eight years’ IT Business Analyst or similar experience in MedTech regulatory environment.
• Fluent in English.
• Experience with Software Validation Life Cycle methodology.
• Ability to collaborate with global stakeholders.

Responsabilidades

• Consult with business stakeholders to understand and evaluate current processes and identify needs, turning them into system requirements.
• Write system functional specifications and support development with testing and quality documentation.
• Deploy new and current systems, processes, and procedures in a cost-effective manner.
• Configure system settings, plan, and execute tests and lead cross-functional teams for regulatory applications.
• Maintain validation documentation per MSCM and ensure compliance with FDA/ISO/EU MDR requirements.
• Ensure information protection and effective collaboration with remote/global teams.

Conocimientos

English fluency

Requirements gathering

Functional specifications

Stakeholder communication

Team collaboration

Educación

Bachelor's degree in computer science or IT

Descripción del empleo

Flexible Work Arrangement

Bogotá, Bogota, Colombia

Full time

R74343

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.

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).

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world




• Grow a career reflective of your passion and abilities




• Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .