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Regulatory Specialist
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- Supports manufacturing/operations day to day activities for change control.
- Provides consultation/advice to regulatory specialist for change control and product development.
- 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.
- Seeking candidate with experience with international (outside of EU and US) product registrations; experience working with medical device operations on control of product release; experience working with electronic change management/document control systems.
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