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