プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

José Daniel C.に依頼

Colombia

Medical Device Regulatory Affairs & Market Access Specialist | LATAM Health Policy

プロフィール概要

Biomedical Engineer, Microbiologist, and Master of Public Health (MPH) with over 5 years of specialized experience in the global medical device industry and healthcare public affairs. My expertise bridges the gap between technical rigor and political strategy. I have a proven track record in global regulatory submissions—specifically managing radiofrequency portfolios and regulatory release—as well as designing healthcare market access networks and stroke care models across Latin America and the Caribbean. Having served as a Senior Public Affairs Analyst for top-tier pharmaceutical and medtech corporations, I excel at political and legislative monitoring, health policy analysis, and strategic stakeholder mapping. How I can help your organization: • Navigating LATAM regulatory frameworks (INVIMA, FDA pathways, etc.) for healthtech innovations. • Designing comprehensive Market Access and healthcare network strategies. • Crafting political risk analyses, stakeholder prioritization, and communication briefs for the health sector.

専門分野

• ☆ Botany
• ☆ Plant Pathology
• ☆ Microbiology
• ☆ Microbiome Research
• ☆ Mycology/Fungi
• ☆ Parasitology
• ☆ Virology
• ☆ Molecular Virology
• ☆ Industrial Microbiology
• ☆ Microbiological Assays
• ☆ Bacteriology
• ☆ Gram-Negative Bacteria
• ☆ Gram-Positive Bacteria
• ☆ Agricultural Microbiology
• ☆ Biostatistics
• ☆ Mathematical Biology
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Structural Biology
• ☆ Enzyme Activity Assays
• ☆ Binding Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Microarrays
• ☆ Omics
• ☆ Transcriptomics
• ☆ Proteomics
• ☆ Genomics
• ☆ PCR
• ☆ Protein Sequencing
• ☆ Cell Biology
• ☆ Membrane Biology
• ☆ Basic Immunology
• ☆ Adjuvant & Antigen Research
• ☆ Biotechnology & Bioengineering
• ☆ Nanobiotechnology
• ☆ Biomedical Engineering
• ☆ Biomechanics
• ☆ Biomimetics
• ☆ Biological Systems Engineering
• ☆ Microscopy
• ☆ Light Microscopy
• ☆ Fluorescence Microscopy
• ☆ Electrical Engineering
• ☆ Electronics Engineering
• ☆ Electronic Circuits
• ☆ Integrated Circuits/Microchips
• ☆ Signal Processing
• ☆ Instrumentation Engineering
• ☆ Wireless Sensor Networks
• ☆ Microwave Engineering
• ☆ Biological Engineering
• ☆ Engineering Education
• ☆ Data Analysis
• ☆ Image Processing
• ☆ Computer Simulation/Computational Modeling
• ☆ Algorithm Design
• ☆ Predictive Modeling & Analytics
• ☆ Data Processing
• ☆ Data Exploration
• ☆ Cluster Analysis
• ☆ Data Visualization
• ☆ Data Collection
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Machine Learning
• ☆ Data Cleaning
• ☆ Business Analytics
• ☆ Statistics
• ☆ Statistical Theory
• ☆ Applied Statistics
• ☆ Comparative Analysis
• ☆ Regression Analysis
• ☆ Multivariate Analysis
• ☆ Correlation Analysis
• ☆ Survey Design
• ☆ Study Design
• ☆ Statistical Review
• ☆ Medical Statistics
• ☆ Health Data Analysis
• ☆ Trend Analysis
• ☆ Bioinformatics
• ☆ Gene & Protein Expression Analysis
• ☆ Systems Biology
• ☆ Structural Bioinformatics
• ☆ Pathogenesis
• ☆ Clinical Microbiology
• ☆ Industrial Biotechnology
• ☆ Biosensors
• ☆ Biomolecular Engineering
• ☆ Tissue Engineering
• ☆ Artificial Organs
• ☆ Medical Technologies
• ☆ Assistive Technology
• ☆ Local Politics & Government
• ☆ Health Policy
• ☆ Public Policy Administration
• ☆ State Policy & Legislation
• ☆ Public Finance
• ☆ Visual Communication
• ☆ Python
• ☆ Matlab
• ☆ Excel
• ☆ STATA
• ☆ LaTex
• ☆ R
• ☆ Tableau
• ☆ Scikit-learn
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ In vitro Diagnostic Design
• ☆ Point-of-Care Devices
• ☆ Biomarker Analysis
• ☆ Lab-on-a-Chip Devices
• ☆ Clinical Trials
• ☆ Human Biology
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ COVID-19
• ☆ Chikungunya
• ☆ Antibiotic Resistance Research
• ☆ Antibiotic Stewardship
• ☆ Tropical Medicine
• ☆ Malaria
• ☆ Dengue
• ☆ Cardiovascular Disease
• ☆ Pacemakers
• ☆ Clinical Cardiac Electrophysiology
• ☆ Cardiovascular Disease Management
• ☆ Clinical Laboratory Science
• ☆ Molecular Pathology
• ☆ Public Health
• ☆ Epidemiology
• ☆ Environmental Epidemiology
• ☆ Pandemic Preparedness
• ☆ Global Health
• ☆ Disease Control And Prevention
• ☆ Public Health and Sanitation
• ☆ Community Health Services
• ☆ Quality of Life Assessment
• ☆ Health Technology Assessment
• ☆ E-Health & Telemedicine
• ☆ Health Informatics
• ☆ Healthcare Administration & Management
• ☆ Hospital & Medical Facility Management
• ☆ Managed Healthcare
• ☆ Medical Practice Management
• ☆ Medical Billing
• ☆ Medical Affairs
• ☆ Healthcare Quality Improvement
• ☆ Social Medicine
• ☆ Wound Care
• ☆ Health Risk Assessments
• ☆ Regulatory Affairs
• ☆ Health Education
• ☆ School Health Services
• ☆ Medical Equipment & Supplies

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Technical Writing, Copywriting, Creative Writing, Newswriting

Research Market Research, User Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Digital Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Predictive Modeling, Statistical Analysis, Algorithm Design-Non ML, Algorithm Design-ML, Data Visualization, Data Cleaning, Data Processing, Data Insights

Product Development Formulation, Product Evaluation, Product Validation, Concept Development, Product Launch Support

職務経験

Universidad de Los Andes

- 現在

Global Regulatory Affairs Specialist

Medtronic

2月 2024 - 現在

Senior Account Executive

Edelman

9月 2025 - 4月 2026

Associate Regulatory Affairs Specialist

Medtronic

5月 2021 - 1月 2024

学歴

Masters of Public Health

Universidad De Los Andes

1月 2023 - 6月 2025

B.Sc. Microbiology

Universidad De Los Andes

8月 2016 - 4月 2021

Biomedical Engineering

Universidad De Los Andes

1月 2015 - 12月 2018

認定資格

• GCP Course for Clinical Trials Involving Investigational Medical Devices

  CITI Program

  https://www.citiprogram.org/verify/?we89cdebf-1554-4311-9ab9-6b5cc26f1a6c-62432574

  4月 2024 - 現在

• Responsible Conduct of Research Biological Sciences

  CITI Program

  https://www.citiprogram.org/verify/?wa2162a96-db12-46a4-a6d7-9fb6f583de1a-62417307

  4月 2024 - 現在

• Advanced information literacy

  State University of New York - System

  https://www.linkedin.com/safety/go/?url=https://coursera.org/verify/VCV92CTEZMZH&urlhash=NTKq&mt=wMwqjJPLyyl4-fWOqoeCSW-XcU-MApBJJy6iZxgrvk3UazKd_oCUj6YmeU8873DogDs5C1geePv1eKAZgT4d5IZ_E94&isSdui=true&lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;F+qbwXt+Q2i38QHb02nWHQ==

  12月 2023 - 現在

• Marketing con influencers: Gestiona campañas efectivas

  Crehana

  https://www.linkedin.com/safety/go/?url=https://www.crehana.com/diplomas/4ab23354&urlhash=nFbP&mt=Llfa5G5nxhRVQAqo1iVoHumYnPR7IPNyve2NS1fpJA2P5chgS61bWHa4HTF5eQMfsYvraYT3eEpcJZq3DWRDdTQV7wI&isSdui=true&lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;F+qbwXt+Q2i38QHb02nWHQ==

  6月 2020 - 現在

• Inbound marketing: estrategia de contenidos

  Crehana

  https://www.linkedin.com/safety/go/?url=http://crehana.com/diplomas/320c1bf5&urlhash=Hbfs&mt=M_yHOn5jHzLmyx7Y23ySY2PYsXW46o6Qct_Wm6K1QSucaRItkWjgw8uB5IGjZOZF1zdEMeFlWh4gygmRux4Vbyp5H40&isSdui=true&lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;F+qbwXt+Q2i38QHb02nWHQ==

  5月 2020 - 現在

• Business Metrics for Data-Driven Companies

  coursera

  https://www.linkedin.com/safety/go/?url=https://www.coursera.org/account/accomplishments/verify/7ZPWXWQVAA6W?utm_source=&urlhash=LnBs&mt=Rr8zyD_gEmhyyK7oqfgi1ZBNrZ7R2wxihgt1mtjmqHoJA15hjgghU6qxRSd3EKARFRga2P6DjCXgNdeVjS3yriTuRfM&isSdui=true&lipi=urn:li:page:d_flagship3_profile_view_base_certifications_details;F+qbwXt+Q2i38QHb02nWHQ==

  5月 2020 - 現在

出版物

JOURNAL ARTICLE

Jose Corredor, Valentina Ardila, Viviana Hernandez, Alejandra Riveros (2018). Optimization of silver nanoparticle biosynthesis by Fusarium oxysporum . 2018 IX International Seminar of Biomedical Engineering (SIB).