Senior Analyst, UDI Master Data - Remote

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.

1. UDI Material Data

o Knowledgeable across all UDI attributes throughout onePLM and QuickBase

o Contribute to data council meetings across all five business units at the Instruments Division and provide knowledge to the product team on gathering UDI material data

o Manage UDI data requests in support of business processes

o Drive excellence and ensure continuous improvement in quality of data through cleansing and data construction

1. Regulatory Submissions

o Knowledgeable in the GUDID (FDA database) & EUDMAED (EU MDR database)

o Lead medical device data submissions to the GUDID and/or EUD

1. Data Reports and Documentation

o Support the business in the creation of UDI reports as applicable

o Create and improve UDI end-to-end system interface documentation

o Knowledgeable in knowing the source system for all UDI attributes and how they interface across our ecosystem

o Develop and maintain relationships with business and IS resources to improve data management processes

o Serve as a business contact for UDI material master related topics while identifying solutions to business challenges

o Partner with cross functional stakeholders to support business needs for UDI material master data

• Bachelor’s degree required, life science related field preferred
• 2+ years of relevant work experience required
• 2+ years of FDA GUDID and PLM experience preferred
• NC/CAPA experience preferred

• USN: $69,500 - $110,900 USD Annual
• Puerto Rico: $69,500 - $110,900 USD Annual
• US5: $73,000 - $116,400 USD Annual
• US10: $76,500 - $122,000 USD Annual
• US15: $79,900 - $127,500 USD Annual
• US20: $83,400 - $133,100 USD Annual
• US30: $90,400 - $144,200 USD Annual