Title: IVDR Regulatory Affairs Specialist 3
Location: NY – Tarrytown 10591
Duration: 12 months
Description:
• 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.
• Upload and QC files in Documentum.
• Experience with SAP.
• Education requirements: Bachelors of Art/Science in a Science related field
• Regulatory Affairs Experience Preferred.
I am looking for 1-3 years of experience.
Education – Bachelors with RAC is preferred or Masters in Regulatory can be nice.
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