Regulatory Affairs and Quality Assurance Expert

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, internal customer document management, and regulatory and quality databases.
  • Provide technical and sanitary product documents, issue letters to customers, and review registration requests received in detail.
  • Ensure timely submission of regulatory dossiers, track regulatory plans and quality assurance planning, and generate improvement proposals.

Internal Networks/Key Relationships

The successful candidate will have strong relationships with customers, external suppliers, marketing managers, department managers/directors, general manager, commercial team, specialists, and technical support team.

Skills and Abilities

The ideal candidate will possess the following core competencies:

  • Analytical skills, numerical analysis, problem-solving, statistical knowledge, negotiation skills, leadership, empowerment, communication skills, systems management, creativity, excellent interpersonal skills, customer focus, integrity, innovation approach, good organizational skills, ability to work under pressure, teamwork, good interpersonal skills, negotiation skills, proactivity, results-oriented.

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

The position requires 10% international mobility.

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