Área de la Empresa | Consultoria Asesoria |
Cargo Solicitado | Asistente de Control de Calidad |
Puestos Vacantes | 1 |
Tipo de Contratación | Tiempo completo |
Nivel de Experiencia | De uno a tres años |
Género | Indiferente |
Edad | 18 / 70 |
Salario máximo (USD) | |
Salario minimo (USD) | |
Vehículo | Indiferente |
País | Guatemala |
Departamento | Ciudad Guatemala |
Job Description
This position is for the Division of Abbott Nutrition in Guatemala.
Objectives:
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Major Responsibilities:
•Responsible for implementing and maintaining the effectiveness of the quality system.
•Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
•Core job responsibilities for this function may include:
•Strategic Planning:
•Assist in SOP development and review
•Provide regulatory input to product lifecycle planning
•Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes
•Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval
•Determine trade issues to anticipate regulatory obstacles
•Determine and communicate submission and approval requirements
•Participate in risk-benefit analysis for regulatory compliance
Education:
•Bachelor's degree in science. Preferred in biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, or medical.
•Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
•Spanish and English advanced.
Experience:
•2 years of experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
•Knowledge of applicable regulatory standards and requirements for infant formula and nutritionals.
Inglés Requerido |
Avanzado |
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