614462

Our 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 Skills:

• 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
• BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.
• Medical Device Background required
• Experience writing regulatory submissions required

Responsibilities:

• 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.
• 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***