Duties:
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Handles regulatory activities involved in documentation, labeling, field support.
• Provides regulatory direction/interpretation on team activities.
• Interprets and applies regulatory understanding to support of products and teams.
• Supports manufacturing/operations day to day activities for change control.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• 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.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
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.
Years Experience:
• 2+ years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function