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.

Responsibilities

• 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 ...