Regulatory Affairs Professional 3

Regulatory Affairs Professional 3
DE - Newark
12+months with possible extension

• Represents RA on design change projects. 
• Communicates regulatory strategy to project teams in the development of verification plans which will enable successful registration of IVDs in U.S., EU, Japan and worldwide. 
• Utilizes FDA guidance documents and historical knowledge to develop and implement regulatory strategy ensuring compliance with FDA requirements. Writes notes-to-file and submits CLIA categorization requests. 
• Prepares dossiers and technical explanations to successfully register IVDs in countries worldwide including Latin America, Asia Pacific, Middle East countries. 

Requirements 
• BA/BS in Science, Engineering or related discipline or advanced degree. 
• 3-6 years of experience in regulatory affairs. 
• Experience on project teams representing RA and bringing new products to market. 
• Knowledge of and experience with FDA regulations and design control requirements for medical devices with preference for IVDs. 
• Knowledge of and experience with global regulatory requirements for medical devices or IVDs. 
• Experience reading technical reports. 
• Experience in a laboratory environment is helpful (e.g., Med Tech background)
Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560 
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com  


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