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Regulatory Affairs Specialist III
Ref No.: 17-03315
Location: Newark, Delaware
Start Date: 04/27/2017
Responsibilities
  • Able to write and understand technical reports
  • Knowledge in regulatory affairs, experience on in-vitro diagnostics, preparation of technical reports are key attributes.
  • Knowledge of international registration requirements is an absolute plus.
  • Prepares technical documentation for in-vitro diagnostic products to support global registrations.
  • Communicates with regional units to ensure understanding of registration requirements.
  • Works with different organizations to assemble technical documentation required.
  • Updates information of submission tracking for registration projects.
  • Basic statistics (product claims)

Knowledge and Experience:
  • Experience in regulatory affairs around In-Vitro Diagnostics.
  • Knowledge of In-Vitro Diagnostic Directives (EU) and international registrations are highly desirable.