Regulatory Affairs and Quality Assurance Expert

hace 1 semana


Bogotá, Bogotá D.E., Colombia Werfenlife SA. A tiempo completo

At Werfenlife SA, we are seeking a highly skilled Regulatory Affairs and Quality Assurance Expert to support the implementation and execution of regulatory and quality plans. As part of our team, you will be responsible for ensuring compliance with RAQA record management processes, leading and managing non-conformities, and preparing regulatory submissions.

Key Responsibilities

  • Support RAQA management with a business focus, ensuring timely submission of regulatory dossiers and tracking regulatory plans and quality assurance planning.
  • Manage non-conformities, follow-up plans for CAPAs, document tracking and control in SAP, and prepare regulatory submissions to INVIMA and other regulatory entities.
  • Lead the preparation and updating of quality agreements, manage regulatory and quality databases, and follow-up on regulatory processes with the factory.
  • Provide technical and sanitary product documents, issue letters to customers, and review registration requests received in detail and provide appropriate responses and support to stakeholders.

Requirements

  • Bachelor's degree in Pharmaceutical Chemistry, Bacteriology, Biomedical Engineering, or Chemical Engineering.
  • Minimum 2 years of experience in Quality Assurance and Regulatory Affairs in the Medical Device and/or RDIV industry.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
  • Intermediate English language skills.
  • Familiarity with ISO 13485 and/or ISO 9001-2015.

What We Offer

  • An estimated salary of $80,000 - $110,000 per year, based on your qualifications and experience.
  • A dynamic and innovative work environment, with opportunities for growth and professional development.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.


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