Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide.

We are seeking a senior-level Principal IT Business Analyst to join the IT Regulatory Systems team, supporting Regulatory Affairs across all regions and operating units. The role focuses on the design and configuration of the UDI platform used to create, manage, and maintain Unique Device Identification data in compliance with global medical device regulations (such as FDA UDI and EU MDR), ensuring traceability, regulatory compliance, supply chain visibility, and patient safety throughout the product lifecycle. The ideal candidate has strong experience in requirements gathering, functional specification writing, working within regulated environments with strict validation practices, and effectively communicating with global business and IT stakeholders.

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

• 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.
  

Required Knowledge and Experience:

• Bachelor’s degree in computer science, Information Technology, or related field. Master's degree preferred
• Fluency in English (minimum C1 level required)
• 8+ years’ experience as an IT Business Analyst, IT Technical Analyst, or software implementation project member with a preferred focus on the MedTech Regulatory industry
• In-depth knowledge of industry best practices and terminology related to the Software Validation Life Cycle Methodology
• Excellent communication and 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
• Ability to work with remote teams of professionals and able to work independently to achieve objectives
• Experience in the MedTech Regulatory industry es advantageous

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).

About Medtronic

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.

Learn more about our business, mission, and our commitment to diversity here