Regulatory Specialist I
1350 East Touhy Avenue Des Plaines, IL 60018 US
Job Description
Experience: 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
Skills:
- Knowledge of regulations and standards affecting IVDs and/or biologics
- Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
Duties:
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Supports manufacturing/operations day to day activities for change control.
- Provides consultation/advice to regulatory specialist for change control and product development.
- Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products 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 wide variety of complex work assignments.
- Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
- Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
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