Regulatory Specialist II at The Fountain Group

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 ­­Scarborough, ME. Details for the position are as follows:

Pay: $47-$56

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.

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.