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Regulatory Affairs Specialist

Katalyst Healthcares & Life Sciences
Montvale, NJ Contractor
POSTED ON 3/18/2024
Responsibilities:
  • RA representative on the R&D cross functional team
  • Identifies standards and target country regulations for the design team.
  • Review Engineering changes including registration impact, risk assessments and review and approve engineering change orders and project documentation.
  • Prepare regulatory submissions, technical files and international product registration documents as needed.
  • Regulatory support for business systems including ERP change management (Form 239).
  • Facilitate all FDA registration and listing related activities.
  • ACE Index Support for Import and Export
  • Manage Recall/Field Action Activities

Hourly Wage Estimation for Regulatory Affairs Specialist in Montvale, NJ
$47.56 to $59.90
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