Sandra Malla Email & Phone Number

Quito, Pichincha, Ecuador

- Compliance with the processes of local and parent company regulatory requirements to obtain Health Registration in Ecuador.- Processing of Registration, Modification of applications for medical devices and drugs in VUE - SENAE ECUAPASS.- Carry out the regulatory impact assessment that is sent globally to Ecuador.- Planned management of databases to identify product traceability.-Coremap for all ISO 13485 documentation, Letters of Authorization, CFG, etc. Touchpoint with internal clients (Marketing and Commercial Team) and external clients (ARCSA)- Management of regulatory platforms (VEEVA RIMS) and global interim bases.

Quito, Pichincha, Ecuador

Specialized in coordinate, plan and execute projects of interest according to the needs of the company. Skilled in taking advantage of the potential of e-commerce, social networks to improve internal processes that impact increased sales and brand positioning to attract the target audience. Competent in developing specialized strategies and solving problems efficiently.

Quito, Pichincha, Ecuador

- Analysis of KPI indicators, metrics and route operations- Compliance with the processes of local and parent company regulatory requirements to obtain Health Registration in Ecuador.- Processing of Registration, Re-registration, Modification and RUO of applications for medical devices in the VUE SENAE ECUAPASS.- Coremap for all ISO 13485 documentation, Letters of Authorization, FDA, etc.- Touchpoint with internal clients (Marketing and Commercial Team) and external clients (ARCSA)- Management of regulatory platforms (RIMS) and global interim bases- Direct support in labeling control, inkjet printing, packaging, import work orders, temperature monitoring, logistics through SAP.- Support in the implementation of changes at the process management level in all areas.

- Generate reports and quality control reports and daily monitoring.- Management of ECUAPASS to submit health records.- Database and consolidated management.- Support from the regulatory affairs and quality assurance area.

Quito, Pichincha, Ecuador

Document management of the accounting department, preparation of withholdings and billing control, internal and external customer service, payment management.

Master In Business Management

The Master in Business Management is capable of: Understand business management theories and concepts to improve organizational.

Business Engineering

The Business Engineer from the National Polytechnic School is capable of designing, implementing and managing organizational systems that.