Senior Analyst, UDI Master Data - Remote

Stryker • Portage, MI

4d • $69,500 - $144,200 • Remote

About The Position

This role focuses on UDI (Unique Device Identification) material data management, regulatory submissions, and data reporting. The Senior Analyst will be responsible for managing UDI attributes, contributing to data council meetings, handling data requests, and ensuring data quality through cleansing and construction. A key aspect of the role involves leading medical device data submissions to regulatory databases like GUDID and EUDAMED. Additionally, the analyst will support the creation of UDI reports, document system interfaces, and maintain relationships with business and IS resources to enhance data management processes. The position requires serving as a business contact for UDI material master topics, identifying solutions to business challenges, and partnering with cross-functional stakeholders.

Requirements

• Bachelor’s degree required
• 2+ years of relevant work experience required
• Knowledgeable across all UDI attributes throughout onePLM and QuickBase
• 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
• Knowledgeable in knowing the source system for all UDI attributes and how they interface across our ecosystem

Nice To Haves

• life science related field preferred
• 2+ years of FDA GUDID and PLM experience preferred
• NC/CAPA experience preferred

Responsibilities

• Manage UDI data requests in support of business processes
• Drive excellence and ensure continuous improvement in quality of data through cleansing and data construction
• Lead medical device data submissions to the GUDID and/or EUD
• Support the business in the creation of UDI reports as applicable
• Create and improve UDI end-to-end system interface documentation
• Develop and maintain relationships with business and IS resources to improve data management processes
• Serve as a business contact for UDI material master related topics while identifying solutions to business challenges
• Partner with cross functional stakeholders to support business needs for UDI material master data

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior