Regulatory Affairs Professional

Regulatory Affairs Professional
Tarrytown, NY – 10591
12 months contract to start with
 
Writing, reviewing and approving technical reports for regulatory submissions for in vitro diagnostic devices 
 Notifying country regulatory colleagues of impending design changes and summarizing global regulatory requirements 
 Preparing regulatory submission packages 
 
 Required Knowledge/Skills, Education, and Experience 
 BS/BA in scientific discipline, or advanced degree, where required, or equivalent combination of education and experience. 
 Minimum 2 – 4 years medical device/in vitro diagnostics assay development and/or regulatory experience 
 Experienced in writing, reviewing and approving technical reports for regulatory submissions 
 Experience with U.S. FDA submissions and knowledge and experience with global registrations of in vitro diagnostic devices a plus 
 
 
Thanks & Regards, 
Imran (Emu) Shikalgar 
APN Software Services, Inc 
39899 Balentine Drive, Suite 385, Newark, CA 94560 
510-402-4704 (Voice & Text) 
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar

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