MBA Graduate Student

• Apr 2022 - Present

Senior Regulatory Affairs Associate

• Apr 2020 - Jun 2022

• Develop and execute regulatory strategies for product registration and renewals. • Prepare documentation to support international registration dossiers and maintain product registration files • Assist with the execution of regulatory submissions such as DMFs and 510ks • Manage and lead standards management processes • SME for labeling and label printing processes • Represent regulatory on product development teams • Help maintain design history files, design… Show more • Develop and execute regulatory strategies for product registration and renewals. • Prepare documentation to support international registration dossiers and maintain product registration files • Assist with the execution of regulatory submissions such as DMFs and 510ks • Manage and lead standards management processes • SME for labeling and label printing processes • Represent regulatory on product development teams • Help maintain design history files, design dossiers, and technical files • Write, revise, and approve documents related to quality systems activities • Manage the electronic quality management system and assist in document control activities • Participate in inspections/audits by external auditing organizations and customers. • Assist with risk assessments and risk analysis • Perform CAPA planning and execution • Perform complaint investigation and reporting • Assist with field actions and recalls • Assist in development of management review content • Execute Post-Market Surveillance activities

Regulatory Affairs Associate

• Apr 2019 - Apr 2020

• Develop and execute regulatory strategies for product registration and renewals. • Prepare documentation to support international registration dossiers and maintain product registration files • Assist with the execution of regulatory submissions such as DMFs and 510ks • Monitor standards for changes in regulatory and quality requirements • SME for labeling and label printing processes • Represent regulatory on product development teams • Help maintain design history files,… Show more • Develop and execute regulatory strategies for product registration and renewals. • Prepare documentation to support international registration dossiers and maintain product registration files • Assist with the execution of regulatory submissions such as DMFs and 510ks • Monitor standards for changes in regulatory and quality requirements • SME for labeling and label printing processes • Represent regulatory on product development teams • Help maintain design history files, design dossiers, and technical files • Write, revise, and approve documents related to quality systems activities • Manage the electronic quality management system and assist in document control activities • Participate in inspections/audits by external auditing organizations and customers. • Assist with risk assessments and risk analysis • Perform CAPA planning and execution • Perform complaint investigation and reporting • Assist with field actions and recalls • Assist in development of management review content • Execute Post-Market Surveillance activities

Host

• May 2017 - Aug 2017

• Directed the logistics and scheduling of the pub’s dining experience and business event functions • Played an instrumental role in seamlessly executing the customer’s experience & gaining dining satisfaction • Efficiently and professionally coordinated server assignments across 54 tables and up to 8 servers uniformly • Evaluated guest satisfaction by investigating and resolving customer service complaints in a timely manner • Directed the logistics and scheduling of the pub’s dining experience and business event functions • Played an instrumental role in seamlessly executing the customer’s experience & gaining dining satisfaction • Efficiently and professionally coordinated server assignments across 54 tables and up to 8 servers uniformly • Evaluated guest satisfaction by investigating and resolving customer service complaints in a timely manner

Intern

• May 2016 - Aug 2016

• Accurately tracked the progress of each individual medical device through the intensive regulatory process • Pulled client information from Salesforce, entered billing metrics then created invoices under supervision • Carefully verified integrity of medical devise database taking initiative to identify and resolve errors swiftly • Performed regulatory research, kept document library current and monitored web for regulatory developments • Accurately tracked the progress of each individual medical device through the intensive regulatory process • Pulled client information from Salesforce, entered billing metrics then created invoices under supervision • Carefully verified integrity of medical devise database taking initiative to identify and resolve errors swiftly • Performed regulatory research, kept document library current and monitored web for regulatory developments