- Prepare and support all submission types for all international geographies for Cardiac Rhythm Management, Heart Failure, and Structural Heart products.- Coordinate global submission and approval timelines for new technologies and International Lead projects.- Review product design, manufacturing, and labeling changes for compliance with applicable international regulations through regulatory assessments.- Contact for international country regulations and product approval status for cross functional teams.- Maintain product approval licenses in Windchill database.- Develop guidelines for auditing, training, eliminating inconsistencies, and improving compliance withWindchill database.- Authored Work Instructions for various regulatory processes including: Latin America Certificates ofConformance and Analysis, Global Regulatory Library, Apostille/Legalization process, and Latin Americasubmission and approval tracker use.- Sharepoint Administrator and SME for the Global Regulatory Sharepoint site.

-Diagnosed regulatory causes of blocked sales orders using SAP Global Trade Services (GTS) application-Supported regulatory product and country experts in releasing new and modified products globally-Trained new employees on Regulatory Operations processes-Assisted Regulatory Operations team members with product releases of all St. Jude Medical products-Collaborated with cross-functional specialties to release products including Customer Service, Supply Chain, Program Management, Marketing, Quality, and Clinical-Delivered query results to original requestors using Business Objects reporting-Integrated acquired company’s products to St. Jude Medical product release process-Worked with clinical affiliates to release products for Emergency/Compassionate Use cases-Authored Standard Operating Procedures and Work instructions for Regulatory Operations procedures-Managed St. Jude Medical Regulatory Sharepoint sites *Managed access to Regulatory Sharepoint sites *Trained all regulatory employees to use Sharepoint sites *Troubleshooted site issues *Created team sub-sites based on team needs outlines by regulatory directors and managers-Awarded Platinum and Gold level Medal of Distinction Awards for excellent contributions to the team

Servicing Product Regulatory Services Small Business Consulting Group-Raw material data management and client follow up-Authored Globally Harmonized System (GHS) compliant Safety Data Sheets (SDS)-Reviewed client product and consumer labels for GHS compliance-Reviewed client SDS and labels for international hazard communication and transportation regulations

Contract worker for 3M Material Resource Division-Supported regulatory business needs for four 3M divisions: Materials Resource Division (MRD), Electronics Materials Solutions Division (EMSD), Advanced Materials Division (AdMD), Home Care Division (HCD)-Extensive use of 3M Regulatory Databases in daily duties and special projects*Chemical Database Management System (CDMS) - Main source of all chemical and regulatory data for 3M experimental, intermediate, and finished goods materials*Product Environment Assessment Knowledge System (PEAKS) - Database for 3M Product Environmental Assessments*Electronic Life Cycle Management System (ELMS) - Globally accessible 3M life cycle management database, single point of data entry for product and regulatory information for US and international uses and applications*SAP Business Objects website (BOXI) - information resource that contains chemical, regulatory, and manufacturing data for all 3M materials*Storage and Tracking - database for new 3M experimental material requests-Assisted with Life Cycle Assessment calculations for EMSD products-Initiated, completed, and issued Electronic Life Cycle documents for EMSD products-Familiar with Globally Harmonized System for Hazard Communication (GHS) compliance and generating GHS compliant safety data sheets-Drove completion of GHS-compliant documents for four 3M divisions-Initiated remediation project for New Jersey Trade Secret numbers and substantiation forms for Home Care and Advanced Materials divisions-Point of contact for MRD and EMSD raw material transportation classification requests -Point of contact for new MRD, EMSD, and AdMD experimental and intermediate material requests-Updated regulatory information for 3m.com/regs website for EMSD products

My work involved diet and cancer prevention research with chemically modified starches and their inhibition of colonic preneoplastic lesions.Specific Responsibilities:-Devised experimental design and maintained four animal studies-Experience with IACUC protocols and guidelines-Experience with in vivo models testing various aspects of resistant starch produced by Iowa State University (ISU)-Collaborated with various members of ISU Plant Sciences Institute Healthy Carbohydrates team-Authored standard operating procedures for animal care, carcinogen safety and handling, carcinogen administration, and animal diet preparation-Successfully characterized and identified preneoplasia in mouse and rat colons-Chemically modified starches in lab bench and pilot plant scales-Managed up to six undergraduate student workers on any given study who each worked 10-15 hours per week -Successful knowledge transfer to incoming graduate student taking leadership on this research.

-Promoted to student manager after one semester as general student worker -Effectively managed up to 20 student workers on any given shift, communicating work procedures and assignments. -Developed efficient set-up and closing procedures-Trained new staff members in all work areas-Directed work groups in opening and closing procedures-Directed work groups to provide fast and optimal service in fluctuating work environment -Tracked current inventory and recommended future inventory purchases -Tracked food consumption for consumption forecasting

Winter seasonal-Customer service.-Lift ticket and rental equipment sales.-Trained new employees-Inventory