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