Preparation and submission of national regulatory applications in the EU region
Process and maintain EU registrations/notifications, renewals, changes, other regulatory activities such as EUDAMED registration
Process and maintain requests to complete distributor letters for: distribution agreements, power of attorney, authorizations to register, product lists, market history, etc.
Maintain published regulatory records and databases in SharePoint, Salesforce and company document control system (Agile PLM) to ensure latest regulatory approved revisions are presented.
Support customer service, marketing, and sales with global market approvals for product shipments.
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