Accomplishments: PURCHASING-Developed numerous new vendor relationships. -Responsible for reducing freight costs 65% over 6 months.- Sourced and designed cartons and laparoscopic shipping containers. - Created and continually monitor and document the Critical Supplier files; Developed Supplier Contracts, Vendor Performance Tracking and Supplier Audits.- Programmed and created Laser Marking machine and templates for inspection.- Sourced and created templates for in house Pad Printing.- Managed and desinged Flexbar Reprorubber single application system.REGULATORY AFFAIRS MANAGER- Creates and maintains Technical Files for Class I and II devices.- Created UDI master labels - Obtained all information necessary for compliant labels. - Wrote QMS procedures for document control, process control, measurement and monitoring equipment, technical file creation, IFU approval, label/package approval, labeling and packaging, new product management form, literature approval, re-evaluation of validated processes, product recall and vigilance, and unannounced audits by EU notified bodies.- Worked with outsourced sterilization facility to prove equivalence to process challenge devices.- Registered products in 20+ countries.- Obtained 10+ product licenses with Health Canada.- Responsible for registration, listing, and certificates of foreign government with the FDA.- Obtained CE approval FlexGuard Retractor Blade Cushion.FURTHER TRAINING- Incoming Inspection - Materials Resource Planning- Internal Audits- Laser marking - Pad Printing- Shipping- Assembly