Corporate Regulatory Affairs Systems specialist

Bogotá D.C Permanente

Fecha de publicación 09/01/2024

  • Experience in RA process for US or Europe
  • English level advanced

Acerca de nuestro cliente

Our client is a well known medical devices company

Descripción

  • Create and maintain regulatory distribution control rules to enable compliant product release in light to product changes, expiration dates, Country of Origin, manufacturing transfers, and supplier changes.
  • Create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.
  • Release and management of RA blocks.
  • Generate and communicate GTS/distribution control reports in a timely fashion.
  • Maintain records (objective evidence) per established procedures.
  • Maintain GTS/distribution control block tracker.
  • Perform and support User Acceptance Testing (UAT) as needed for RIMS and GTS.
  • Work closely with global RA teams and Global Customer Operations to resolve issues related to GTS/distribution control blocks, batch determination rules, and maintenance of objective evidence.
  • Upload and maintain RA data in RIMS, Batch Determination, and GTS system using automated upload tools and troubleshoot data errors as needed.

Perfil buscado (h/m)

We are looking for our next << Corporate Regulatory Affairs Systems specialist >> who is going to provide support for the maintenance and implementation of RA systems, with particular focus on Regulatory Information Management System (RIMS) and Regulatory Distribution Controls through SAP. This person will create and maintain regulatory affairs registrations and licenses in RIMS/GTS distribution control systems in support of regulatory controls for global product distribution.

Candidate must be:

  • Bilingual (English B2 or above)
  • Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
  • A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required.
  • Have knowledge of EU, EMEA, APAC, LATAM, or US regulations pertinent to medical devices, biologics, drugs and combination products.
  • Software Skills- SAP modules, SAP GTS, ERP systems, Microsoft Office Suite, Adobe Professional and Excel for data analytics
  • Attention to detail and capable of working in an organized and consistent manner.

Qué Ofrecemos

  • Great and competitive salary and benefits package.
  • Good company's culture and work environment.
  • Hybrid work model
Contacto
Roger Ramirez
Ingresar referencia para vacante
JN-012024-6295253

Resumen de empleo

Sector
Healthcare & Life Sciences
Sub Sector
Registros
Sector
Healthcare / Pharmaceutical
Ubicación
Bogotá D.C
Tipo de Trabajo
Permanente
Nombre del consultor
Roger Ramirez
Job Reference
JN-012024-6295253

En Michael Page creemos en la diversidad e inclusión. Defendemos la igualdad de oportunidades sin discriminar por género, raza, edad, religión ni orientación sexual o por cualquier otro aspecto que pudiera ser considerado excluyente.