Regulatory Affairs/Quality Assurance Specialist in Webster, TX for 445 W Medical Center Blvd, Webster, TX 77598
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Regulatory Affairs/Quality Assurance Specialist
Ansh Labs is hiring a Regulatory Affairs/Quality Assurance Specialist to implement and manage the Company’s domestic and international Regulatory Affairs (RA) procedures, and Quality Management System (QMS) procedures to support its business and release marketed In Vitro Diagnostics products ensuring adherence to established requirements to current and upcoming regulations. This position will also ensure that product and product related documents are processed in compliance with established procedures, including Change Control Orders (CCO), Device History Records (DHR), Manufacturing Work Instructions (MWI), Standard Operating Procedures (SOP), Quality System Manual (QSM), and Quality Control System (QCS).   Responsibilities include but are not limited to:


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