Medical Equipment Quality and Regulatory Coordinator
hace 2 semanas
**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**
- Quality Assurance.
- 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.
- 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**:
- sanitary registrations
- medical devices
- regulatory affairs
- quality assurance
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