José de Jesús Espinosa De la rosa

Recaptured lost registrations and restored profitability in LATAM markets. Led initiatives to increase approvals and address Government questions. Developed Latin America master dossiers to facilitate and expedite the submission process with the purpose to increase revenue as well as eliminate backload. Developed relationships with manufacturing sites, contract manufacturers and applicable cross-functional areas to obtain key information requested on successful meetings with Health Authority experts. Recommended In- Country strategies for earliest possible approvals based on submission pathways- Analysis to obtain marketing authorization on the Aortic Peripheral Vascular portfolio

Responsible for developing and applying regulatory strategies for new products, product changes and product renewals to ensure market access for Cardiovascular and Diabetes products. Coordinate and execute submission plan aligned to local regulation and local business needs to guaranteed product launch. Working with cross-functional teams in order to provide regulatory support to drive business and address issues that impacted the company. Provide regulatory support for: *government tenders, *importation issues *distributors *Asian countries support for product manufactured in Mexico

Main activities include: management of medical devices (functional aids, prostheses, medical equipment, hygiene products, surgical instruments), food supplements and medicines. Preparation and coordination of regional submission plan based on schedule for optimal launch. Support to the commercial areas for the development of products art works, review and approval of promotional material and support in government tenders. Coordination of Latin American countries as Mexico, Chile, Uruguay, Peru, Paraguay, Panama, Costa Rica, Venezuela, Bolivia, El Salvador, Guatemala, Honduras, Nicaragua, Ecuador and the Caribbean Islands

-Support for the coordination of technical and legal translations. -Support in the application and monitoring of local documentation to different manufacturing sites. - Review and approval of the graphic arts. - Review and approval of promotional material. - Support in the bidding process in Mexico and Latin America. - Support activities for ophthalmic drug and medical devices registrations.

-Support regulatory affairs area in various processes with CANIFARMA and COFEPRIS. -Import permits, promotional materials, variations of the conditions of registration, assignment of rights, corrections, sampling visits, response to deficiency letters. -Preparation of registration dossier. Translations-English-Spanish, Spanish-English. -Updating and creating databases.