Senior Analyst, UDI Master Data - Remote
Stryker · Portage, Michigan, United States · $70K–$144K/yr
Medical Equipment Manufacturing · 10,001+ employees
About the role
The Senior Analyst will manage UDI material data, ensure data quality, and lead medical device data submissions to regulatory databases like GUDID and EUDMAED. They will also develop system documentation and partner with cross-functional stakeholders to support business needs.
What they look for
Requirements
A bachelor's degree in a life science-related field is required, along with at least 2 years of relevant work experience. Candidates should have experience with FDA GUDID and PLM systems, with NC/CAPA experience being preferred.
Full description
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
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 10%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
