Plasma Regulatory Affairs Associate

Job Number: 365571

Category: Regulatory

Description: Job Title: Plasma Regulatory Affairs Associate
Location: Durham, NC
Pay rate: $28 - $35/hr.
Zip Code: 27701
Area Code: 919, 984
Start Date: Right Away
Keywords: #DurhamJobs; #PlasmaRegulatoryAffairsAssociateJobs;

Summary:
Plasma Regulatory Affairs oversees the licensing, surveillance, and other regulatory activities associated with Source Plasma collection within the United States of America, Canada and Rest of World (ROW). This includes activities associated with US Food and Drug Administration (FDA) licensure and registration (biologics (BLA), medical device), Health Canada licensing, Clinical Laboratory Improvement Amendments (CLIA) activities, Plasma Protein Therapeutics Association (PPTA) membership and certification, COLA accreditation, state/province requirements and ROW licensing activities as applicable.

Primary responsibili...