Regulatory Affairs Specialist

hace 1 mes


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

Overview

Job Summary:

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

About the Role:

  • Collaborate with RAQA management to drive business objectives.
  • E nsure compliance with RAQA record management processes.
  • Lead and manage non-conformities, follow-up plans for CAPAs.
  • Document tracking and control in SAP.
  • Support regulatory submissions to INVIMA and other regulatory entities.
  • Prepare and update quality agreements.
  • Manage internal customer document management.
  • Regulatory and quality databases management.
  • F ollow-up on regulatory processes with the factory.
  • F ollow-up and preparation of meeting and committee minutes.
  • Provide technical and sanitary product documents.
  • Issue letters to customers.

Budget and Benefits:

The ideal candidate will have an estimated annual salary of $80,000 based on industry standards and location. This role also offers a range of benefits, including professional growth opportunities, and a dynamic work environment.

Skills and Qualifications:

  • Education: Higher education in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
  • Experience: Minimum of 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
  • Additional skills/knowledge: Computer skills, including Word, Excel, and PowerPoint. Intermediate English language proficiency. Knowledge of ISO and/or ISO-13485.

International Mobility:

This position requires occasional international travel (up to 10% of the time).



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