Senior Analyst, UDI Master Data
Portage, WI - USA
Job Summary
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
- Bachelors 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: $69500 - $110900 USD Annual
- Puerto Rico: $69500 - $110900 USD Annual
- US5: $73000 - $116400 USD Annual
- US10: $76500 - $122000 USD Annual
- US15: $79900 - $127500 USD Annual
- US20: $83400 - $133100 USD Annual
- US30: $90400 - $144200 USD Annual
Required Experience:
Senior IC
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more