Regulatory Affairs-biomedical engineering

BREA BREWINGTON

**** ********* **** * *** **** • Plymouth, MN 55446 • 336-***-**** • ********@*****.***

EDUCATION North Carolina Agricultural and Technical State University December 2015

Master of Science Bioengineering

North Carolina Agricultural and Technical State University May 2012

Bachelor of Science Chemical Engineering

Lean Six Sigma, Black Belt Certification January 2017

TECHNICAL SKILLS

ASPEN, MatLab, Solid Works, AutoCAD, IBM SPSS, Experimental Design, Scale-up, Computational Biology, QI Macros, Thermal Analysis, Statistical Analysis, Microsoft Office, Scanning Electron Microscopy, X-Ray Fluorescence, Aseptic Techniques, PCR, Chromatography, HPLC, Freeze Drying, Cell Culturing, Chromatography, Mass Spectrometry, Pipetting skills, SOPs, HIPPA, CMS Portal, ICD-9/10, Electronic Medical Records, Biomechanics with Finite Element Methods, Process Control Systems, Scaffolds, Engineering principles, Design of Engineering, cGMP, FDA Regulations, Medical Device Regulations and Standards (US, Europe, Canada and International)

WORK EXPERIENCE

Associate Regulatory Affairs Specialist, Blood Management Medtronic Minneapolis, MN January 2017- Present

Fulfilled role as subject matter expert for 3 Blood Management product lines (In-vitro Diagnostics), which included providing primary regulatory support for all related sustaining projects. IVD, Class I & II

Knowledge of FDA medical device regulations and ISO standards (ISO 13485, 21 CFR 820, EU Medical Device Directive, Canada regulations)

Provided support for CAPA tasks for supported products

International regulatory (China PTR, India, Taiwan QSD, Brazil RDC-40)

Knowledge of 510(k)

European TUV Notified Body Submissions

Advised in the creation and implementation of new design control procedures and dFMECAs.

Prepared and submitted 30+ CFGs for US approval and consularization to support global registrations.

Reduced completion time of international requests by 40%, utilizing Lean Six Sigma tools for process improvement.

Collaborated with cross-functional teams for various projects, giving a regulatory perspective.

Managed and oversaw 70+ updates of the European and Malaysian Declaration of Conformity project.

Developed and implemented an easy to use business guidance for international requests program, InSight, for regulatory to utilize.

Served as liaison for the Stand Alone Assembly (SAA)/STED Management project, converting 163 ECT product families information from Agile to InSight and RAD for geography Regulatory Affairs Specialist, finishing at 100%.

Accounts Receivable Specialist LabCorp McLeansville, NC July 2016 – December 2016

Read and understand SOP’s for working denials or correspondence.

Determined next best action according to SOP’s for denials from insurance carriers.

Updated invoices with current billing information to bill insurance carriers and secondary coverage.

Understand Explanation of Benefit statements to bill patients.

Appealed claims for denials.

Microbiology Lab Research Assistant NC A&T State University Greensboro, NC August 2013 –December 2015

Oversaw lab experiment preparation by preparing petri dishes, streaking plates, agar, and autoclaving.

Worked independently in Microbiology lab to prepare various medias for the designated labs, including the necessary calculations.

Designed research project investigating how microgravity affects bacterial biofilms.

Cell cultured and freeze-dried bacteria (P. aeruginosa, S. aureus., H ducreyi).

Collaborated with staff while conducting research.

Studied scientific journals, abstracts and other literature to improve technical knowledge.

Center for Academic Excellence Math Graduate Teacher Assistant NC A&T State University Greensboro, NC August 2014 – December 2015

Delivered academic assistance to 86 students taking Intermediate Mathematics, College Algebra & Trigonometry for Engineers and Scientists I & II.

Coached study sessions using techniques and strategies to help students with weak math skills.

Led after hours supplemental instruction sessions and tutoring for students for test day with a pass rate of 93%.

Design Engineering Co-Op Southern Nuclear Company Baxley, GA January 2010 – May 2010

Assisted with ensuring the reliability of assigned plant systems and corrected plant P&ID diagrams.

Identified and documented small bore piping at Plant Hatch susceptible to flow accelerated corrosion.

Prepared technical basis for Request for Engineering Review for re-gearing of Metal Oxide Varistor (MOV).

Inspected new nuclear fuel bundles during Plant Hatch refueling outage.

Utilized AutoCAD to design P&ID diagrams for the plant systems

Designed heat exchangers using SolidWorks

Aided in developing Heat Exchanger Program Database to retrieve and record data on fleet wide heat exchangers.

Chemistry Lab Internship Duke Energy Sherrills Ford, NC May 2008 – August 2008

Obtained plant process liquid samples for analysis.

Handled Caustic Acid deliveries to the plant.

Worked with treatment systems used to produce high purity water and boiler chemistry regimes for corrosion protection.

Assisted with catalytic reduction systems, regeneration and backwashing of demineralizers.

Analyzed plant process liquid samples for chemical additive concentrations to ensure system health and compliance.

Created project studies and work order in Promet to be put into the 5-10 year budget plan for Marshall Steam Station.

Participated in O2 testing to determine if boiler tubes were cracking due to lack of oxygen.

LEADERSHIP, HONORS AND MEMBERSHIPS

Feed My Starving Children Volunteer • TRIO-Student Bridge Program Tutor (Summer 2014 & 2015) • Biomedical Engineering Society (2015-2016) • National Society of Black Engineers (NSBE) (2007-2018) • Society of Women Engineers (SWE) (2007-2012)• American Institute of Chemical Engineers (AIChE) (2007-2012) • Student Health Advisory Committee-Student Lead (2009-2011) • Dean’s List(2007-2008) • Emerging Leaders Workshop attendee (2007-2009) • Goodwill Volunteer (2013) • Senator Alma Adams Campaign Volunteer (2008-2011) • Mayor Yvonne Johnson Campaign Volunteer (2012)

RESEARCH/PUBLICATIONS

Thesis, “The Effect of Microgravity on Pseudomonas aeruginosa Susceptibility to Contact Lens Solutions and Adherence to Contact Lenses.” Brewington, Brea, Advisors: White, C.D. Dr., Yun, Yeoheung Dr., Department of Biology, Department of Chemical and Bioengineering, North Carolina Agricultural and Technical State University, Greensboro, North Carolina. 2015 http://search.proquest.com/docview/176*******

Department of Biology 2nd Place Research Award

“The Effect of Saline, Water, Alcohol, and Biotrue Contact Lens Solution on the Adherence of Pseudomonas aeruginosa and Staphylococcus aureus on Soft Contact Lenses”. Brewington, B.E, White, C.D., Dr, Department of Biology, North Carolina Agricultural and Technical State University, Greensboro, North Carolina, 2012

NC-Louis Stokes Alliance for Minority Participation, 8th Annual OPT-ED Alliance Conference

“The Sonolytic Reactor Synthesis of Iron and Rare Earth Metal-based Nanostructured Materials”. Moore, G.L., Brewington, Brea, and Roberts, K.L., Dr., NSF, NC-LSAMP, 8th Annual NC OPT-ED Alliance Conference, Department of Mechanical and Chemical Engineering, North Carolina Agricultural and Technical State University, Greensboro, North Carolina, 2009 & 2010.

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