About the Job

Work Flexibility: Remote

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

2. 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

3. 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

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