Karen Marquina Castillo

I contribute to achieve the Abbott’s Diagnostics Division goals through efficient and effective obtaining of the authorizations for its products. My tasks was the following:

• Planning strategies for submit and obtain new registrations, modifications and/or renewals for Abbott’s products to market them opportunely.
• Submit and obtain import and publicity authorizations for Abbott’s products.
• Assembly expedients of Abbott’s new products to obtain its authorizations from COFEPRIS.
• Request of information with global regulatory affairs department and manufacturers to build the expedients.
• Sending the documentation, that will form part of the expedients, to translate.
• To collaborate with other areas to achieve marketing of the products correctly.
• To analyze and resolve the regulatory impact of technical and administrative changes in the products to avoid problems with the importation.
• Optimizing the resources to do productive the obtaining process of the authorizations from COFEPRIS.
• To review the advertising materials according the current regulations to obtain publicity authorizations from COFEPRIS.
• Request of import authorization.

• Preparing and submitted of Marketing authorization of Medical Devices class I and II in Latin America (Ecuador, Colombia and Brazil) and development and implement strategics according with the FDA process.
• Request of 510k at FDA.
• Request and submitted technical and administrative variations.
• Development of Risk Analysis to request at FDA.
• Development and implementation of Check list for the standardization of income and submission of health registration requests according to the legislation of each country in Latin America.
• Request of export authorization.

• Preparing and submitted of Marketing authorization of Medical Devices and Medicines in México.
• Request of import authorization.
• Request of Free Sale Certificate.
• Request of import authorizations and distribution of hemoderivate products with the corresponding releases.
• Planning strategies for submit and obtain new registrations, modifications and/or renewals opportunely for all kind of products.