Regulatory Compliance and Quality Assurance Professional

hace 2 meses

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

About the Position

Job Summary

We are seeking a highly skilled Quality Assurance and Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen. The ideal candidate will have a strong background in Quality Assurance and Regulatory Affairs, with experience in the Medical Device and/or RDIV industry.

Key Responsibilities

  • Support RAQA management with a business focus, ensuring compliance with regulatory requirements and industry standards.
  • Lead and manage non-conformities, follow-up plans for CAPAs, and document tracking and control in SAP.
  • Prepare and submit regulatory submissions to INVIMA and other regulatory entities, ensuring timely and accurate submissions.
  • Develop and maintain quality agreements, and manage internal customer document management.
  • Manage regulatory and quality databases, and follow-up on regulatory processes with the factory.
  • Prepare and update meeting and committee minutes, and 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.

Managed Budget (if applicable) & KPI

  • Ensure timely submission of regulatory dossiers, and track regulatory plans and quality assurance planning.
  • Generate improvement proposals, continuous development, and involvement in projects.

Internal Networks/Key Relationships

The ideal candidate will have excellent communication and interpersonal skills, with the ability to work effectively with customers, external suppliers, marketing managers, department managers/directors, and general manager.

Skills and Abilities:

  • Strong analytical and problem-solving skills, with the ability to negotiate and lead teams.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.
  • Strong knowledge of regulatory requirements and industry standards, with the ability to stay up-to-date with changing regulations.
  • Ability to work under pressure, with a strong attention to detail and organizational skills.

Minimum Knowledge and Experience Required for the Position:

  • 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. Language: Intermediate English. Knowledge of ISO and/or ISO-.

International Mobility:

  • Required: 10%

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