Regulatory Specialist II

614462Our client, a leading Medical Device company in Alameda, CA, is looking for a Regulatory Affairs Specialist II to provides consultation/advice to regulatory specialist for change control and product development.Required **2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs functionBS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Medical Device Background requiredExperience writing regulatory submissions requiredProvides 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.Responsible for implementing and maintaining the effectiveness of the quality system.Supports manufacturing/operations day to day activities for change control.Compensation within this range will be commensurate with level of experience**

Created: 2024-11-06