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USA

Regulatory Data Entry

locationSparks - Maryland (MD),

atKatalyst Healthcares & Life Sciences

Job Description:

RESPONSIBILITIES:
  • Assists Labeling Data Analyst with maintaining master Life Sciences UDI project plan and strategy for compliance with EUDAMED and other regional databases for China, S. Korea, Australia, etc.
  • Executes activities for collecting, verifying, approving and maintaining the integrity of data attributes in a timely and concise manner.
  • Ensures that all standard data entries and
summaries are statistically valid.
  • Responds to internal and external requests for data through the preparation of ad-hoc queries and reports.
  • Supports priorities with UDI/eIFU/MDR/IVDR workstreams to ensure the overall success of the relevant programs/projects.
  • Suggests tools and processes that provide technical guidance and metrics that enhance program workflows, data entry, and submissions.
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