Medical Equipment Regulatory Affairs Coordinator

hace 2 semanas


Tláhuac, Ciudad de México Worldwide Asian global leading manufacturer, developer and distributor of medical devices A tiempo completo

Vacante para la empresa Worldwide Asian global leading manufacturer, developer and distributor of medical devices en Benito Juárez, Ciudad de México:

Worldwide Asian global leading manufacturer, developer and distributor of medical devices requieres:

Medical equipment regulatory affairs/Quality assurance coordinator
Ensure that the company has all documents (Licenses, Importations permits, SOPs, certifications, or any other document) and that the activities are performed according to the Local requirements of the countries for which the companyis responsible (Mexico, Cuba, Caribe, Dominican Republic, Guatemala, Honduras, El Salvador, Nicaragua, Costa Rica, Panama, Colombia, Peru, Ecuador, Bolivia & Venezuela), allowing the commercialization of our medical devices

Main Accountabilities

  • Get Licenses (Sanitary Registrations for medical devices group products)
  • Assembling dossiers and submitting them to the local Governmental Institution responsible of it.
  • Local compliance for commercialization of the product in the respective countries.
  • Maintenance of current licenses.
  • Gathering documentation, according to local requirements, for amendments or renewals of Licenses
  • Keep Licenses updated and valid for commercialization of the products according to the current portfolio.
  • Support to distributors for their licenses obtention our maintenance
  • Gathering documentation, according to local requirements, for amendments or renewals of Licenses
  • Keep Licenses updated and valid for commercialization of the products according to the current portfolio.
  • Quality Assurance.
  • Local compliance with regulation

We offer

  • Very competitive compensation
  • Benefits superior to those established by law
  • International growth and continuous training

Nível de educación deseada:

Superior - titulado

Nível de experiência deseada:

Nível Experto

Función departamental:

Medicina / Salud

Industria:

Dispositivos Médicos

Habilidades:

- medical equipment
- regulatory affairs
- quality assurance

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