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 specialists for change control and product development.
• Provides regulatory direction / interpretation on team activities. Interprets and applies regulatory understanding to support products and teams.
• Prepares U.S. regulatory submissions and registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, and field support.
• Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance with the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance with and demonstrates knowledge of site and division-level policies and procedures.

Years Experience : 2-5 years regulatory experience and / or 2 years 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.