Laura Camila Jiménez Guzmán

Bioengineer with more than 4+ years of experience in Regulatory Affairs for the Americas region. Solid background in data management on Oracle platforms as Business Intelligence (OBIEE- BI).
Passionate about the development of new technologies in the medical and pharmaceutical industries. Excellent capabilities to lead projects and be innovative to improve processes.
Active listener, with high analytical skills and critical thinking. I love working with multidisciplinarity teams to promote cultural diversity and continuous learning.
 

Bioengineer with more than 4+ years of experience in Regulatory Affairs for the Americas region. Solid background in data management on Oracle platforms as Business Intelligence (OBIEE- BI).
Passionate about the development of new technologies in the medical and pharmaceutical industries. Excellent capabilities to lead projects and be innovative to improve processes.
Active listener, with high analytical skills and critical thinking. I love working with multidisciplinarity teams to promote cultural diversity and continuous learning.
Analysis and evaluation of the impact of changes related to Design, Labelling, Manufacturing Site, Manufacturing Process, Sterilization, Stability, Raw Material, Software Version, Packaging, Supplier, and Legal Documentation, among others, across all lines of business according to Latam and Canada regulations using RID creation through MAP Agile.

Act as a strategic ally in all regulatory activities by:

· Establishing and managing entities within the InSight and Webtop platforms, meticulously preparing registration files to align with regulatory protocols for presentation.
· Taking an active role in processes involving changes, renewals, and new product introductions, collaborating analytically with functional groups to craft monographs.
· Constructing, upkeeping, and continually enhancing databases and documentation repositories for LatAm and Medtronic tools (utilizing Smartsheet), designed to meticulously track the advancement of regulatory procedures through key performance indicators (KPIs).
· Providing steadfast assistance for GTS Blocks and Batch Blocks, in addition to monitoring tools for business units.
· Participating in the RAD CAB as the administrator for LatAm, overseeing projects and standardizing procedures on both the global and regional scale for the InSight and Webtop platforms.

Successfully Executed Projects: CAPA Resolution - Enhancing data related to each type of approval across the entire Latam region to establish comprehensive regulatory traceability within both the InSight and Webtop systems.

Data management through extraction, analysis, and processing to modeling or building statistical models and presenting financial, supply chain, human resource, sales, manufacturing, and customer relationship reports through the platform of Oracle Business Intelligence using the development environment SQL Developer.

Bachelor of Bioengineering