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Regulatory Affairs Professional

Company: Infosoft Inc
Location: Newark
Posted on: February 14, 2020

Job Description:

Job Title: Regulatory Affairs Professional Pay Rate: $30 to 34/Hr Duration: 12 Months Job Requisition: JP00059782, JP00059786 Location: Newark/DE or Tarrytown/NY This position is for Healthcare Diagnostic division Maintain technical files for in vitro diagnostic products in compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR Prepare and review technical file submissions for reagents, calibrators, controls and verifiers against relevant standards. Provide regulatory review of the claims and technical files to maintain EU CE marking. Investigate and close GAPs in documentation for technical files. Support e-filing by reviewing and logging files to be uploaded into Documentum. Experience with SAP. Bachelors of Art/Science in a Science related field Regulatory Affairs Experience Preferred. - provided by Dice

Keywords: Infosoft Inc, Newark , Regulatory Affairs Professional, Other , Newark, Delaware

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