Regulatory Affairs Associate

  • Location
    Allendale, New Jersey
  • Job type
  • Category
    Information Technology - Project Manager

Regulatory Affairs Specialist Job Summary: Support Project Sapphire (PLM system upgrade) Regulatory Affairs track. Review, analyze, report and categorize Regulatory Affairs documents such as regulatory submissions, registrations, technical files, design dossiers, regulatory change assessments, labels and IFUs.

Pay: $78/hr

Must be proficient in Microsoft office (Work, Excel, Outlook). Regulatory experience (1-2 years) required. Regulatory Affairs Specialist Additional Job Details: This "Sapphire" project is moving to a Global PLM system (Product Lifecycle Management). Candidates need to be an excel expert, able to organize large bundles of data to present to manager. Work independently and ability to troubleshoot independently. The data to be reviewed and analyzed includes US regulatory submissions, EU technical files and design dossiers, regulatory assessments, labels and IFUs. Additional data such as regulatory registrations and listings, and supplier or OEM product information. Candidate is expected to work independently and be able to troubleshoot independently. Strong communication skills are necessary. Project Management skills are a plus.

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Reference number US_EN_2_022862_401223