Regulatory Compliance Specialist Data Analyst

JOSHUA ISRAEL CORRALES CASTILLO

B.SC BIOLOGY EMPHASIS AT BIOTECHNOLOGY

ID: 116520173 Tel: (506-****-**** ***********@*****.*** Professional Summary

Strategic Data Professional with a foundation in Biology and a specialization in Biotechnology, combining scientific precision with data-driven thinking. Experienced in regulatory affairs, quality assurance, and complaint management within the pharmaceutical and medical device industries. Proficient in regulatory compliance (FDA 21 CFR, ISO 13485), quality management systems (GMP, CAPA, QMS), and data analysis using Excel, Python, SQL, Power BI, and Tableau. Skilled in document review, risk assessment, regulatory submissions, and project management methodologies. Recognized for delivering customer service excellence and fostering effective cross-functional communication in fast-paced, regulated environments. Fluent in English (B2+) and committed to continuous learning and strategic impact.

Education

● High School Diploma Liceo de Heredia (2009-2013)

● Bachelor’s Degree in Biology with Emphasis in Biotechnology Universidad Nacional de Costa Rica (2016-2019)

Certifications}

● The Project Management Course – Udemy – (2025)

● Revenue Cycle Management and Medical Billing for Beginners – Udemy – (2025)

● Fundamentals of Financial Services – Udemy – (2025)

● Financial Statements: Balance Sheet, Income Stmt, Cash Flow – Udemy – (2025)

● Introduction to Financial Products & Services – Udemy – (2025)

● Foundations of SAP ERP: Master the Basics – Udemy – (2025)

● Excel Skills for Insurance Professionals – Udemy – (2025)

● Financial Planning & Analysis: Building a Company's Budget – Udemy – (2025)

● Professional Certificate in Regulatory Compliance – Udemy – (2025)

● Best Excel Course: Data Cleaning - For further Data Analysis – Udemy – (2025)

● Project Management Fundamentals: Run projects effectively – Udemy – (2024)

● Introduction to Agile : Scrum and Kanban – Udemy – (2024)

● The Business Intelligence Analyst Course 2024 – Udemy – (2024)

● Python Essentials I; Data Science Fundamentals & Data Analytics – CISCO (2024) Access 100+ certifications & licenses on my LinkedIn profile. Experience

Patient Financial Specialist Health Prime Jan 2025 - Present

● Oversee end-to-end patient billing and revenue cycle processes using Epic Systems. Ensure the accuracy and timeliness of financial transactions between providers, patients, and insurance carriers, enhancing operational efficiency and reimbursement outcomes. Complaint Management Analyst Genpact Sep 2022 – Sep 2024

● Investigated and resolved pharmaceutical product complaints under FDA 21 CFR 820, GMPs, and ISO 13485, applying data analysis and data visualization techniques using Excel and Power BI to communicate key insights to cross-functional teams. Call Center Agent Concentrix March 2022 – Sep 2022

● Assisted customers with revenue tracking and service-related inquiries. Pre-access Agent UCB Intelligent Solutions Sep 2021 – March 2022

● Facilitated authorization of medical outpatient procedures between hospitals and insurance companies. Sterilization Technician Precision Concepts MT Mar 2020 – Jun 2020

● Ensured sterilization process compliance with ISO 11135, ISO 11137 for medical devices. Laboratory Technician National Nanotechnology Lab Jun 2019 – Mar 2020

● Conducted chemical and microbiological experiments, applying ISO laboratory standards. Skills & Competence

● Data Science & Analytics (Python, SQL, Excel, Tableau, Power BI)

● Project Management & Methodologies (Waterfall, Agile, Scrum, Project Planning, Risk Management, Gantt Chart)

● Generative AI & AI Tools (ChatGPT, OpenAI, Copilot, Machine Learning)

● AI Regulations & Standards (EU AI Act – ISO 42001)

● Quality Management Systems (ISO 9001 – ISO 14001 – ISO 10012– ISO 31000 – ISO 31010)

● Quality System Regulation, ICH GCP, GMPs (FDA 21 CFR 820 – 21 CFR 58)

● Medical devices Regulation, Risk Management & Biological Evaluation (ISO 13485–ISO 14971 – ISO 10993)

● Sterilization of Health Care Products (ISO 11135 – ISO 11137 – ISO 11138)

● Customer Satisfaction & Guidelines for Complaints (ISO 10001 – ISO 10002)

● Cleanrooms & Controlled Environments (ISO 14644)

● Operational Excellence, CAPA System & Processes Improvement Methods

● Quality Tools, Root Cause Analysis, Risk Assessment Techniques

● Microsoft Office (Word – Excel – PowerPoint – Visio – Publisher)

● English (B2+ level – CEFR)

● Biotechnology Techniques & Applied Chemistry Instrumentation References

● Jorge Luis Ulate Sancho

Contact: +506-****-****; **.***********@*****.***

● Esteban Delgado Navarro

+506-****-****; *******.*******@****.**.**

● Daniel Corrales Miranda

Contact: +506-****-****; **********@*******.***

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