Regulatory Specialist II
2 weeks ago
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.
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