Senior Analyst, UDI Master Data

StrykerPortage, MI
Remote

About The Position

This role focuses on UDI (Unique Device Identification) Master Data management, contributing to data council meetings, managing data requests, and ensuring data quality. It also involves leading medical device data submissions to regulatory databases like GUDID and EUDAMED, creating UDI reports, documenting system interfaces, and collaborating with business and IS resources to improve data management processes. The position serves 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

Nice To Haves

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

Responsibilities

  • 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
  • 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.
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