- Title: Regulatory Affairs Associate
- Code: RCI-ABT-77392
- Location: Des Plaines Illinois (IL) 60018
- Posted Date: 05/14/2019
- Duration: 6 Months
- Status: Open
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
2+ 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.
- 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.