Regulatory Affairs Specialist

hace 4 días


Bogotá, Bogotá D.E., Colombia Werfen A tiempo completo

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen.

Key Responsibilities

  • Ensure compliance with regulatory and quality record management processes.
  • Lead and manage non-conformities, follow-up plans for CAPAs.
  • Document tracking and control in SAP.
  • Regulatory submissions to INVIMA and other regulatory entities.
  • Preparation and updating of quality agreements.
  • Internal customer document management.
  • Management of regulatory and quality databases.
  • Follow-up on regulatory processes with the factory.
  • Follow-up and preparation of meeting and committee minutes.
  • Provide technical and sanitary product documents.
  • Issue letters to customers.

Requirements

  • Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
  • Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
  • Computer skills, including Word, Excel, and PowerPoint.
  • Intermediate English.
  • Knowledge of ISO and/or ISO -.


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