Jean Carlo Ortiz Lawrence

Professionally driven individual with a strong passion for quality science and a comprehensive skill set. Specialized expertise in compliance, regulatory guidance, medical devices, industrial processes, statistics, distribution, planning, analysis, project evaluation, and numerical analysis. Proficient in leadership, critical thinking, time management, creative problem-solving, and conflict resolution. Known for a eagerness to learn, adeptness in overcoming challenges, and agility in adapting to dynamic environments with a positive attitude and unwavering commitment.

QA COMPLIANCE SPECIALIST
NEVRO | COSTA RICA| MARCH, 2023 - PRESENT
-Thoroughly review and analyze complaint files to ensure adherence to regulatory standards.
-Promptly address complaint and quality compliance issues, such as Regulatory decision, MDR submission, an closing case adequate. -Gather and assess customer and patient data to evaluate product-related concerns, while ensuring compliance with company and regulatory requirements.
Extra activities:
-Development of procedure to facilitate no company compliant submissions in accordance with FDA guidelines.
-Enhancement of existing SOPs to align them more effectively with compliance standards and bolster their robustness.
-Creation of a document with justification of current approches in compliance process and decision making.
-Boosting of current process and sample scenarios for supplier notification to prompt awareness to the correct supplier.
JR SUPPLY CHAIN PLANNER
SMITH & NEPHEW | COSTA RICA | OCTOBER, 2022 - MARCH, 2023
-Executed orders in SAP in accordance to the defined global strategy. Inventory management, allocated inventory, created deliveries, and identified/managed exceptions to improve the customer experience. -Conducted analysis to determine the application of flow and inventory strategies for the Global Inventory Network. Reviewed and enhanced existing KPI's.
-Created and conducted analysis on sets orders and their issues that can interrupt the release of materials.
Extra activities:
-Helped standardization on the department email responses. -Implemented forms to improve distribution and coordination of team members on different duties.
GLOBAL REGULATORY COMPLIANCE ANALYST
SMITH & NEPHEW | COSTA RICA | MARCH, 2021 - OCTOBER, 2022
-Processed complaints in an accurate, uniform, and timely manner for the orthopedics, wounds, and robotics franchise.
-Managed the Robotics franchise mail by assigning in a timely manner the Department reponsible for complaints to acheive the established metrics of Regulatory Federation.
-Monitored continously the information gathered and tracked missing information necessary of complaint status.
-Tracked open, in process, and complete complaints/products investigations/follow-ups internally and externally for quality determinations in a continously manner.
-Overviewed closure verification so complaints can be inside metrics and not affecting the countries’ necessary reports.
Extra activities:
-Created a tool on Power BI to acknowledge complaints that are pending a Regulatory Report with the correct investigation result. -Designed flow charts for the wound department.
-Standardized failure modes on Intakes for S&R.
-Organized and Improved the processing of intakes in literatures and PMCF

TECHNICAL DEGREE,
DATA ANALYTICS
Tecnológico de Costa Rica | 2023 - 2024
BACHERLOR DEGREE, INDUSTRIAL ENGINEERING Universidad Fidélitas | 2017 - 2020