Principal it business systems analyst

Descripción del cargo

We are seeking a senior-level experienced Principal IT Business Analyst to join our IT Regulatory Systems team which supports the Regulatory Affairs functions within all operating units and regions.
Primary focus will be on the design and configuration of our UDI platform, via which we create, manage, publish, and maintain Unique Device Identification data in compliance with global regulatory requirements in the Medical Device industry (e.g., FDA - GUDID, EU MDR - EUDAMED, etc.).
Its core purpose is to ensure device traceability, regulatory compliance, supply chain visibility, and patient safety across the full product lifecycle.

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.

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