Applied my regulatory expertise to assist in business development

• Perform quality and fulfillment support for a virtual Class I medical device company• IMSXpress Quality System Software Proficiency• Followed Standard Operating Procedures (SOPs)• Regulation (EU) 2017/745 (MDR) deep dive gap analysis work on technical files for leading medical device companies (Class IIb devices, specific areas of focus include: IFU and CER)• Perform extensive research of clinical databases including PubMed, FDA web• Redesign Clinical Evaluation Reports (CERs) for Class III medical devices to MDD• Create a new CER for a Class IIb medical device to MDD• Provide 1:1 attention and small group support for client• Knowledge of eSubmissions to the FDA• Support preparation of a breakthrough device submission• Knowledge of Agile and Windchill document management system• Interim Executive Assistant to the CEO: February 2019-April 2019

• Performed pack audits, examined process flow of the product lines and completed product cook tests• Collected samples of product to run die measurements and moisture analysis, inspected incoming raw product, inspected final product for damage• Formulated processed wheat COAs for sister company in Minneapolis

• Worked in Northern Great Plains in wind, heat, cold, rain, and hiked through tall grasses, barbed wire, electric fences and cattle to reach the plots. Worked for Battelle Ecology Inc. on the NEON (National Ecological Observatory Network) project as part of the Battelle Memorial Institute• IACUC Training, implemented and revised SOPs, team environment, long hours in the field (early morning-late evening)• Entered field data in real-time using a Mobile Data Recorder (Small Mammals, Mosquitoes, Beetles, Phenology, LAI, Clip, Diversity, Ticks)