Hello,

This is ShivaRaj from The Fountain Group, we are currently seeking a Regulatory Specialist II for a prominent client of ours.

This position is located in Santa Clara, CA. Details for the position are as follows :

Pay : $60-56

Experience :

2-5 years regulatory experience and / or 2 years relevant industrial experience typically with a quality, product-development / support, or scientific affairs

Skills :

Knowledge of regulations and standards affecting IVDs and / or biologics / Medical device

Education :

BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

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 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.
2 days ago