Regulatory Data Entry
Sparks - Maryland (MD),
Katalyst Healthcares & Life Sciences
- 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.