Alina Stubbs Email and Phone Number

• Author US Class II and European Class III Medical Device Submissions (five 510(k)s & four Design Dossiers)• Determine global regulatory pathways for various projects• Regulatory member of product design teams and transfer teams, defining regulatory requirements of U.S. and European Submissions• Process Certificate of Foreign Government through FDA CDRH Export Certification Application and Tracking System (CECATS)• Update and manage site’s Medical Device Listings through FDA Device Registration and Listing Module• Analyze and make recommendations regarding field complaints and corrective/preventive actions• Participate in and assists with FDA facility inspections & lead Notified Body audits• Internal Audit various functions in the organization to ensure quality compliance• Review and approve engineering change notices, assessing regulatory impact

December 2012 - Thomas Medical Products, A GE Healthare Company was acquired by Merit Medical Systems, Inc.• Managed Site Internal Audit Program• Facilitated and Coordinated Product Recalls/Field Actions• Medical Device Reporting to FDA • Assisted in filing Domestic/International Product Submissions (510k, Design Dossiers) • Issued Customer Return Material Authorizations• Assisted in developing procedures to ensure regulatory compliance

• Authored Customer Service Standard Operating Procedures, Work Instructions & Technical Guides• Maintained departmental and functional procedures and maintain 100% compliance to company Quality Management System• Monitored new product sales and generate reports for use by Marketing and Sales• Performed the customer service function for the company (Process Customer Orders and Credits and Returns)• Invoiced all customer purchase orders• Interfaced with customer base and European colleagues on a regular basis

Interpreted and applied Pyle contracts as well as foreign contract tariffs Audited eight customer accounts to ensure correct pricing was appliedPerformed the Unknown Product Description, Density Classification, Inside Delivery and Daily Photo Audit for all customersHandled rate calls and emails involving customer quotes, sales and accounts receivable requests, classification, balance due and rating issues

Responsible for the accurate handling of customer quotes and orders using Great Plains and the MQS (Marvin Quoting System)Assisted the outside sales force with sales issues and served as a liaison between Marvin Windows and the selling dealerProvided estimated time of arrivals of order using Marvin Order SystemCreated product drawings and located products efficiency data and standard features using MDS (Marvin Design System)