Job duties- Gather, verify, and deliver product data under the European Union Medical Device Regulation (EU MDR) regulatory requirements for unique device identifiers (UDIs) in medical devices.
- Collect and analyze the records of medical device data from one or more data sources that flow into SingleSource Excel.
- Support SingleSource Excel upload of medical device data.
- Troubleshoot and ensure that data loads successfully with latest SingleSource Excel template.
- Perform medical device data gathering, data cleaning, and data validating to ensure that data successfully loads into SingleSource and structured according to business requirements.
- Verify medical device data from companies reporting to health authorities in import logs generated in SingleSource;
- Record and analyze errors found in SingleSource and create error resolution spreadsheets with list of errors encountered during data flow process.
- Ensure that the integrated data source system is updated with required medical device data changes.
- Submit data editor inquiries to Regulatory Affairs for approval and submit approved records to health authorities from SingleSource.
- Reconcile with Data Loaders to resolve record approval rejections or facilitate edits and approvals from health authorities.
- Utilize Microsoft Visio to present and plan the Data operations and process of data flow to SingleSource;
- Integrate the source system with required data changes and coordinate with business teams to resolve any data migration issues to SingleSource;
- Support population of head-mounted device data submissions to SingleSource during trials for medical device vigilance data.
- Gather and analyze UDI data in EUDAMED databases via SingleSource.
- Position may require working at various unanticipated work locations throughout the United States.
Minimum Requirements- At a minimum, a U.S. Bachelor's degree in Computer Science, Data Analytics, Informatics/Health Informatics, or a related field, or the foreign degree equivalent.
- 2 years' experience in the job offered or any related occupation.
- Strong understanding of the EU MDR Regulation for UDI data requirements.
- Experience performing medical device data gathering, data cleaning, and data validating using SingleSource Excel.
- Experience submitting UDI data to EUDAMED databases.
- Experience with SQL and other database tools.
- Applicants must also be willing to work at various unanticipated work locations throughout the United States.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.