IVDR Regulatory Affairs Specialist 3

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. 
 ‘

Want to apply later?

Type your email address below to receive a reminder

Apply to Job

ErrorRequired field
ErrorRequired field
ErrorRequired field
Error
Error
insert_drive_file
insert_drive_file