Principal Regulatory Affairs Specialist (Remote Consultant) in Medtronic’s Navigation Division• Drafted and submitted European Union (EU) Medical Device Regulation (MDR) technical documentation for a variety of navigated cranial, spinal, and ENT (ear, nose, throat) medical devices including software. The risk classifications of the devices in scope include classes III, IIb, IIa, I sterile, I reusable, and I.• Analyzed deficiencies in the technical documentation drafting and review processes. Utilized analysis to develop targeted strategies and project management tools for subject matter experts that facilitated and streamlined the creation and review of documentation. This reduced the documentation submission timeline by more than two weeks.• Managed and coordinated subject matter experts while drafting responses to questions from regulatory bodies to obtain regulatory approval. • Analyzed questions from regulatory bodies to implement process improvements in procedures that created more compliant outputs to reduce future repeat questions from regulators.• Created teaching tools including PowerPoints, work instructions, and templates that facilitated learning for junior team members; commended by manager for their improved quality of work.

Regulatory Affairs Specialist II (Remote) in BD’s Urology and Critical Care Business Unit• Provided regulatory and technical guidance to project teams on 11 EU Medical Device Regulation (MDR) remediation projects.• Initiated and led a team of 5 colleagues to analyze and consolidate regulatory technical documentation that saved the business unit in regulatory costs and hundreds of resource hours in regulatory documentation maintenance every renewal cycle (5 years).• Successfully negotiated the reclassification of a Class III (highest risk) medical device to Class IIb ahead of its EU MDR submission.• Created and led a strategy to address the MRI Safety of products through testing and material analysis to ensure proper MRI Safety labeling.• Co-led audit preparedness for the Japanese portion of the Medical Device Single Audit Program (MDSAP) and helped the business unit obtain certification.

European Regulatory Affairs Specialist• Drafted, submitted, and maintained technical documentation for the 6 product lines available in the European Union including the company’s premier cardiac, implantable device.• Drafted standard operating procedures, work instructions, and templates, some of which were first of their kind, for the business to comply with the Medical Device Regulation and relevant standards.• Reviewed testing protocols/reports and drafted rationales by utilizing previous testing data to avoid the additional cost of retesting.• Collaborated with the Quality and Corrective and Preventive Action (CAPA) teams to address deficiencies in our Quality Management System.• Drafted and reviewed clinical evaluation reports (CERs) in coordination with the Clinical Manager to address the Medical Device Regulation and Medical Device Directive in compliance with MEDDEV 2.7.1.

Regulatory Affairs (RA) Specialist in Stryker’s Joint Replacement Division• Appointed interim manager of international RA. Oversaw two RA Specialists and the communication, drafting, and review of technical documentation to support international submissions and audits.• Drafted technical documentation, liaised with subject matter experts and notified bodies to address deficiency questions in a timely manner for 3 Medical Device Directive (MDD) certificates, obtaining renewals for all 3 certificates.• Fostered and coordinated cross functional team support and preparation to transition to the new EU Medical Device Regulation (MDR) from the previous EU Medical Device Directive (MDD).

Regulatory Affairs Intern• Researched FDA regulations on dental and oral surgery products and designed regulatory strategies to help bring these products to market.• Communicated with both domestic and international manufactures to determine which products and strategies serve the best interest of the startup.• Conducted risk and market analysis on the different products, manufacturers, and regulatory strategies, then presented my findings to the CEO and other members of the startup.

Research Assistant for Gregory T. Clement in the Center for Devices and Radiological Health.• Conducted research on the Optical Imaging of Acoustic Transients to help identify deficiencies transducers.• Set up a laser system to be used as an Interferometer to image ultrasound waves through different mediums.• Security Clearance: Public Trust valid until 2023

Graduate Ambassador• Hosted networking events with the Office of Graduate Admissions in the School of Engineering and Applied Science.• Maintained and organized student files and forms through Adobe Acrobat, Target X (CRM), and GW Docs.• Recruited prospective students and met with professors, alumni, and industry representatives.

Nanotechnology Fellow under Professor Saniya LeBlanc• Utilized Scanning Electron and Atomic Force Microscopy to characterize nanostructures.• Worked in clean rooms with the equipment for fabricating and processing silicon wafers.• Designed photomasks using CAD software and a roller apparatus in SolidWorks.Accomplishment: Modified a 3D print box into a powder spreading rig for Dr. Leblanc’s Energy Materials Analysis for Additive Manufacturing by Selective Laser Melting Research Project and presented a poster at GWU’s Research and Development (R&D) showcase.

Research assistant for Professor Murray H. Loew• Conducted research for the Infrared Thermography Breast Cancer Detection and Salience Analysis of Mammograms projects.• Wrote code in MATLAB to analyze and quantify breast images.• Presented information and status updates at weekly laboratory meetings with the professor and other students.Accomplishment: Presented a poster on the Salience Analysis of Mammograms research project at GWU’s Research Days showcase.

Maintained office computers, devices and software such as ECW (eClinical Works)Communicated with patients by scheduling appointments, conducting outpatient calls, and answering patient inquiries. Shadowed Dr. Rhodes on geriatric house call rounds.