Amy Deuchler Email & Phone Number

California, United States

-Drive global labeling changes for new product release and sustaining product updates for Class III cochlear implant devices and accessories-Create, support, and review activity related to labeling, including, content creation and updates, activity for product launch, change orders, electronic instruction for use (eIFU) processes, country product list and country inclusion list updates, first article inspection reviews.*Contract placement with Maven Wise

Baxter Healthcare (Consultant)• Facilitated implementation and compliance with the European Union Medical Device Regulation (EU MDR) for all classes of medical devices• Provided regulatory medical device labeling subject matter expertise to project teams• Reviewed and approved Labeling Requirement Specifications (LRS) and labeling artwork

Greater Chicago Area

• Provided regulatory labeling expertise towards the development of SOPs, Work Instructions, Guidance Documents and Templates that result in streamlined and efficient labeling processes for a large global pharmaceutical company• Supported regional product launches and labeling updates for medical devices, pharmaceuticals, biologics, and combination products for multiple clientsKEY ACCOMPLISHMENTS• Successfully compiled and analyzed pain points collected during interviews and on-site workshops with client participants. Data directly influenced the process development and content of a newly restructured labeling organization and cross-functional written procedures for labeling.• Authored a PRA white paper highlighting global labeling regulations, guidance documents, and best practices for medical device labeling

Round Lake, Il

• Negotiated strategy and facilitated development of labeling requirements and content with cross-functional teams for new product launches of medical devices, biologics, and combination products in global markets• Mentored and led core and extended team members across Baxter towards consistent and continuous improvement in key labeling initiatives such as UDI, EU MDR, RoHS, global labeling compliance, and design controlKEY ACCOMPLISHMENTS• Successfully led the development and implementation of a global electronic labeling (eIFU) regulatory process, including interpretation, procedure development, website requirements and readiness, operational methods, and training/socialization within 6 months of project initiation• Drove measurable labeling improvements in labeling strategy, requirement and content tracking, electronic labeling (eIFU), UDI, and gap identification by developing and implementing templates, job aids and metrics collection for labeling initiatives• Drove labeling requirement and content development for ~15 Baxter Top Projects (Class III devices) across multiple global business units while meeting accelerated development and submission timelines

Round Lake, Il

• Represented device labeling on Core teams for top initiatives, including: UDI / xUDID and Master Item Data platform development, China RoHS requirements, Relabeling remediation, Regulatory Intelligence, and Electronic Instructions for Use (eIFU)• Mentored immediate team and cross-functional team members towards consistent and continuous improvement in labeling compliance, regulatory intelligence, Global Labeling repository usage, and UDI interpretationKEY ACCOMPLISHMENTS• Developed and implemented a robust Global Labeling Requirement / Intelligence repository (GLAM) and Document Library archive and drove continuous improvement of repository towards ~80-90% user satisfaction rate• Developed and implemented a labeling gap analysis template and companion metrics to track overall “labeling health” and identify opportunity for improvements• Represented regulatory labeling on cross-functional teams for global UDI / xUDID platform development and data governance, labeling tracking databases, and Global Item Master initiatives• Drove Baxter participation in 2015 FDA Home Use Labeling pilot to influence change in electronic labeling regulations• Successfully represented Baxter as a Presenter at Marcus Evans’ 3rd Annual Global Device Labeling Strategies Conference (Minneapolis, MN 2015), showcasing device labeling regulatory intelligence and global labeling database concepts

Waukegan, Il

• Provided regulatory labeling development and review for a broad range of new and sustaining products sold globally, including Medline and private labeled OTC pharmaceuticals, cosmetics, convenience kits, medical foods, all classes of medical devices, and related Ad/Promotional material• Performed SPL registrations for all Medline and select customer accounts• Provided regulatory support and review of product sourcing documentationKEY ACCOMPLISHMENTS• Successfully submitted 500+ FDA SPL registrations and food facility registrations for Medline and private label OTC pharmaceuticals• Reviewed packaging and promotional labeling for compliance with FDA, EPA, CPSC, EU, and Health Canadaregulations with a 97% review turnaround time within 48 hours• Streamlined multiple departmental procedures to reduce training hours and increase effectivity and productivity• Received award for “Quality Person of the Quarter”, 2nd Quarter, 2012

Mundelein, Il

- Reviewed packaging and promotional labeling for OTC pharmaceuticals, cosmetics, medical foods, and medical devices for compliance with US (FDA, EPA, CPSC), European Union, and Health Canada regulations (97% review turnaround within 48 hours, approximately 650 reviews per quarter)- Submitted (sole owner) SPL submissions for all Medline and private label OTC pharmaceuticals (500+ submissions)- Submitted and maintained 30+ food facility registrations

• Submitted SPL submissions for 50+ OTC pharmaceuticals and three NHP applications to Health Canada• Developed regulatory content and reviewed OTC pharmaceuticals and cosmetic product labeling• Investigated customer product quality complaints

•Re-organized contract information in MediTract contract database for multiple hospital sites

• Reviewed design specification documents, technical manuals, and finished good BOMs• Managed bi-weekly cross-functional meetings for Change Control System (CCS) database• Created and update Quality System documentation• Created and managed approval process for BOMs and change orders for finished goods and components (85% of total)

•Maintained less than a 24 hour turnaround on creating accurate part number assignment and bills of materials in the business system; guided documents through approval process; assisted other departments in retrieving and interpreting part documents •Implemented 85% of all Engineering Change Orders (ECR/ECO) for part number and structure revisions in IFS ERP system•Assisted the Technical Publications team with creating new and updating existing technical documents

• Coordinated electrical equipment installations from bidding phase through install phase: obtained bid requirements, interpreted technical drawings, formulated pricing, purchased equipment, coordinated shipments and scheduled installations (55-65% of company revenue)• Provided customer service and inside sales support to customers for equipment sales, rentals, and lighting projects (20-50% of company revenue)

• Operated at a less than one day order entry cycle time for customer equipment orders (Oracle 11i)• Maintained the highest return rate of the department for Return Material Authorizations (RMA)• Reduced departmental cycle time of domestic Out-of-Box Failure Orders from 7 day average to 2 day average replacement time (Six Sigma project)

Mlis

Certificate

B.A.