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