Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day-to-day activities for change control. Provides regulatory direction on team activities. Applies basic regulatory understanding to support of product and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation, labeling, field support.
Applies regulatory and technical knowledge to a focused area of work assignments. Understands, implements, and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
Knowledge of regulations and standards affecting IVDs and/or Biologics. Bachelor's Degree preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
Minimum 0 years regulatory experience required. Desire 1-2 years of regulatory experience preferably in in-vitro diagnostics. RAPS Certification preferred.
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