Curriculum Mayela Rodríguez V.
COMPANY SMITH & NEPHEW (DECEMBER 2019-MARCH 2020)
GLOBAL REGULATORY COMPLAINCE VIGILANCE (UE and USA) Temporal position (Project)
• Author Medical Device Reports Vigilance, MDRs, MedWatch for the NCA in EU and USA, ensuring timely transmission to the appropriate regulatory authorities.
• Incident submission through the BSI platform.
• To verify the adverse event report according with the reportability matrix.
• To coordinate with the local QARA according with the country regulation. ACHIEVEMENTS
• To submit the adverse event report to the NCA in time according with the sanitary regulation. COMPANY JOHNSON & JOHNSON DE COSTA RICA S. A. (FEBRUARY 2019–MAY 2019) REGULATORY AFFAIRS SPECIALIST FOR CENTRAL AMERICA, CARIBBEAN AND SOUTHAMERICA Temporal position (Project)
• To verify and correct the regulatory strategy per country made for the project.
• Documents request for the dossier preparation for each product and country for the project.
• To coordinate the documents translation required for the dossier according with the country needs.
• To preparer, compile, review and assembly the Dossier for each country and product, to support the regulatory process.
• To execute the sanitary submissions for: inscription or modification, extensions and changes for the license, in time through the different Health Authorities.
• To coordinate with the consultants about the regulatory process involve with the project. ACHIEVEMENTS
• To execute the sanitary certificates inscriptions and post approval in time according with the project established. REGULATORY AFFAIRS CONSULTANT AND CHEMICAL REGENT (JANUARY 2019- CURRENTLY) RESPONSABILITIES
• Counseling in regulatory process, sanitary classification, requirements per product, according with the customer needs.
• To execute the sanitary certificates inscriptions and post approval according with the customer needs.
• Lobbying with the Authority for the regulatory process required for the clients.
• Regulatory Documents virtual library management.
• Sanitary Regent processes, storage conditions for the products, SDS translation and technical documents.
• To elaborate the transportation sheet for chemicals, and other sanitary documents required for the products importation.
• To get the Sanitary license or the Authority resolution for the regulatory processes.
• Customer satisfaction about the consultant services. MAYELA RODRÍGUEZ V.
cédula: 1-12830965, Tel 88-24-56-36, firstname.lastname@example.org Industrial Chemist and Industrial Engineer Master. Experience in Multinational Companies in: Medical Devices, Drugs, Cosmetics, Hygiene products. With capabilities and skills as: leadership, planning, negotiation, communication, analytical, customer service, focus in results and continuous improvement. Experience in: Regulatory Affairs, Research and Development, Quality Control, and Customer Service. Curriculum Mayela Rodríguez V.
COMPANY ESSITY CENTROAMERICA S. A.
REGULATORY AFFAIRS SPECIALIST FOR CENTRAL AMERICA (MAY 2016 – JANUARY 2019) RESPONSABILITIES
Actively Participate in the Central America projects and initiatives, to provide inputs and regulatory requirements for the product development (ingredients, labelling, claims, advertising and packaging), from inception to launch and post approvals.
To coordinate with marketing, labeling design, technical area, trade-marketing, supply and sales for the regulatory process according with the project development and launch times.
To determine the Regulatory Strategies for each Regulatory Procedures and to define the regulatory documents required, according with the business need.
To preparer, compile, review and assembly the Dossier for each country and franchise, to support the regulatory process in Central America.
To execute the sanitary submissions for pre-market and post-market products as: inscription, renewal, post approval and line extensions for the license, in time through the different Health Ministries; electronic or in paper according to the country regulation.
Active communication with the consultants, and sanitary representatives in Central America.
Attend queries and Health Authority additional requirements for the submissions.
Maintain and Control Regulatory Status.
To support commercial area with the regulatory documents required for tenders.
To validate the artworks and labeling for new products and promotional material and digital copy.
To have updates of the new Central America Regulations, Laws and normative; and Global regarding to the different Health Authorities.
The regulatory process implementation in Central America. In two years we had a systematic and effective regulatory process.
To have the sanitary license approvals for new products in time according with the project planning.
To execute the 100% of the regulatory process through the Health Ministry in Costa Rica.
To Influence those, involve in regulatory issues as: quality control, marketing, technical product, labeling design, planning, supply, to align the regulatory needs and requirements to be in compliance in Central America and with the business.
To execute the company name change in to the sanitary license every country in Central America.
100% labeling alignment for the SKU, to be in regulatory compliance.
Regulatory Affairs implementation through Regents, to have a more effective process, and cost reduction near 42%.
COMPANY AQUAPURA S.A.
WATER TREATMENT CONSULTANT, CUSTOMER SERVICES JULY 2011 –OCTOBER 2015 RESPONSABILITIES
Customer service from previous sales to post sales service.
Customer consultant about the water treatment, according with the customer needs, kind of water, application and investment.
To execute the water test and to design the equipment required for the customer.
To prepare the sales plans for the wholesaler’s customer. ACHIEVEMENTS
The after sale service was implemented; this service increases the sales in 4 million of colones each month.
Create a customer service database including: first contact, equipment installation, and post-sale service. Greater order and access to information was achieved.
New analysis method and lab equipment were implemented for the water samples.
During the 2013 I exceed the sells goals and got a 48% sales growth over the previous year.
I was awarded as the Employee of the year, 2012. Curriculum Mayela Rodríguez V.
Industrial Engineer Master, Instituto Tecnológico de Costa Rica.
Industrial Chemist Bachelor, Universidad Nacional de Costa Rica, May 2010. OTHERS
Data Mining Expert, PROMIDAT, currently.
Online Training of Regulatory Excellence & Networking, February, 2020.
Effective Communication: Assertiveness and emotional intelligence, Grupo Dando Costa Rica October 2018.
Positive Influence, Grupo Dando Costa Rica, S. A., June 2018.
Chemist Regent Certificate, Colegio de Químicos de Costa Rica, December 2017.
MINITAB Quality Trainer, May 2016.
Process Management, ECA, November 2015.
Six Sigma Black Belt, Instituto Tecnológico de Costa Rica, December 2013.
Occupational Health, INA, May 2010.
Microsoft Office, Minitab, SAP, Sharepoints, regulatory platforms, Pilgrim. PROFESSIONAL ASSOCIATIONS AND COMMISSIONS
ASOCORES, Costa Rica
PROFESSIONAL ASSOCIATION OF CHEMIST, Costa Rica
DRUGS AND MEDICAL DEVICES COMMISSION, COSTA RICA.