Work Flexibility: Remote
1. UDI Material Datao 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
2. Regulatory Submissionso Knowledgeable in the GUDID (FDA database) & EUDMAED (EU MDR database)
o Lead medical device data submissions to the GUDID and/or EUD
3. Data Reports and Documentationo 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
Education / Qualifications- 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
United States of America Pay Ranges:- 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
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%
