Regulatory Affairs Specialist

David L. Loeser

**** ****** ******, *** ***

Fresno, CA 93612

***********@******.***

251-***-**** Cellular

REGULATORY AFFAIRS WRITING SKILL SET

● New Drug Application (NDA)

● Pathways to approval (510k), (PMA)

● Electronic common technical document (eCTD)

● Clinical Trial Consent Form

● Proper document to deliver to an IRB

INFORMATICS SKILL SET

● Electronic Health Records Systems (EHR)

● System

● Visio

● Agile Project Management

● TFS, SQL, JIRA, ALM, AZURE

EDUCATION

Northeastern University M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices March 2018 College of Professional Studies – Boston, Massachusetts University of South Alabama B.S. in Health Informatics May 2014 School of Computing – Mobile, Alabama

● Recipient of the Daniel Genz award for overcoming extreme adversity, and first Health Informatics graduate

● Dean's List – Spring 2012

CAPSTONE PROJECT

Bitome, Boston MA Winter 2018

Consultant, 510(k) Advisement and Submission Analyst

• Direct consultant to stakeholders on regulatory pathways, De Novo, 510(k), and PMA

• Identified predicate devices for a table top thoracic impedance fluid monitoring device to be used by CHF patients

• Educated stakeholders on the FDA 510(k) pathway to market approval, using multiple predicate devices, product codes and opportunities to attend pre-submission meetings with the FDA

• Attended an FDA Software Pre-Certification Software workshop at NIH

• Conveyed to stakeholders that their device can have the operating software approved through an accelerated program and needs to be included in 510(k) submissions

• Presented to stakeholders and classmates that the FDA is working to accelerate 510(k) approvals using real world evidence and the importance in identifying specific predicate devices that have well documented post market surveillance

• Final deliverable to be a thesis paper including sections of 510(k) submission and a displayable poster to classmates and stakeholders

EXPERIENCE

Family HealthCare Network, Fresno, CA June 2018 – Current Health Informatics Specialist

• Participated in a major ambulatory system conversion. o 300 End users, 2 locations in Fresno County

• Validate “Go Live” functionality on hardware and software

• Drafted new workflows for Medical Assistants, Nurses, and Providers

• Provided technical support to ensure input/output devices were properly online using TCP/IP Becton Dickinson and Company, Reston VA July 2017 – October 2017 Business Analyst, Requirements Engineer

Digital Health, Integrated Diabetic Management

• Analyzed, advised engineers, developers and project managers about two Diabetic Medical Devices currently being developed

o Class II Device engineered to measure insulin delivery from a prefilled insulin pen o Class III Device engineered wearable disposable insulin pump

• Advised on regulatory requirements to integrate both devices into Becton Dickinson’s first consumer mobile platform, Diabetic Integrated Management

• Reviewed FDA Guidance documents, new regulations, policies, and guidelines. Advising upper management about gaps, risks, and appropriate corrections to ensure delivery of safe and efficient medical devices.

• Liaised with corporate regulatory department on identifying 510(k) predict devices, and organization of clinical data to use for pre-market submission to the FDA

• Worked with a team and the product owner of Becton Dickinson’s first consumer-facing mobile application,

“Briight” Version 1.0 release October 1, 2017, to the Apple App Store and Google Play Store

• Wrote user stories and technical requirement based on business needs and product owners wants for future releases of “Briight.”

• Performed backlog grooming for current sprints and in preparation for upcoming sprints

• Attended lean agile project management meetings with QA, developers, UX, and project managers.

• Oversaw TFS database operations and utilized it with pre-developed SAP software to write the PRD and other deliverable documents to upper management

hCentive, Reston, VA July 2015 – January 2017

Business Analyst, Health Insurance Exchange Specialist

• Informed senior stakeholders of the Massachusetts Health Insurance Exchange (MAHIX) project on a variety of software assurance and computer science problems

• Implemented and configured software packages that formed the basis of a modern well-functioning health insurance exchange

• Prepared, presented weekly reports of the probable consequences or failures related to implementation of business needs

• Write and edit functional system documents, produce professional Visio workflows

• Test development of new integrated functionality with QA teams

• Participate in daily meetings with developers, review, analyze and adjust all requirements as needed to ensure efficient production and completion of all JIRA tickets

• Participate in debugging and tracking meetings with Optum stakeholders, report on progress, troubleshoot challenging JIRA tickets with all team members, and compile monthly individual completion results Mary’s Center - Capital Clinical Integrated Network (CCIN), Washington, DC January 2015 – July 2015 Business Analyst, HIT Implementation Specialist

• Designed supporting data flow and workflow diagrams using Visio

• Wrote users stories after interviewing all end users

• Provided implementation team with new interface modules

• Selected to participate with George Washington Hospital in the development of Prevention at Home HIV testing information system

• Design wireframes for various modules, map data LOINC, CPT for lab module

• Worked with DCPCA on various telemedicine hardware, including demonstrating CCIN telemedicine equipment using Acano application in real time

• Worked closely and developed strong relationships with CCIN RN’s, CHW’s, C level executives and incorporated knowledge into the development of “Syntranet Electronic Medical Record System” (SEMR) to satisfy end users’ needs

• Managed IT ticketing system, resolved end-user issues, advised on best practices for proper system usage and security measures using iOS app

• User fields not propagating data correctly, duplication of patient data, connecting D.C. hospitals to local physicians, failed acknowledgment

• Liaise with SEMR support and CCIN IT, directed weekly updates and meetings with SEMR support

• Lead recent SEMR upgrade, managed all Q&A with RN’s and CHW’s

• Collaborated with SEMR support to integrate outbound and inbound faxing

• Developed various modules of SEMR system and CCD using HL7 protocol for proper health information exchange performance

• Provided tier 1 and tier 2 support to CCIN end users

• Upgraded training documentation for SEMR

• Trained CHW staff in small groups on new SEMR features, answer IT questions, correct user error with positive peer to peer feedback

• Tested proper execution of movement of ADT, CCD data to and from SEMR to HIE to eClinical Works and vice versa

• Participated in management sustainability meetings in an Agile project management environment USA Children’s & Women’s Hospital, Mobile, Alabama October 2012 – May 2014 Business Analyst/Student Assistant

• Worked as part of a team responsible for the project migrating a large hospital to a Nextgen EHR system

• Documented physician workflow using Visio

• Reported to implementation team design interface including user stories

• Completed daily team and individual performance goals with no supervision

• Coordinated a chart implementation process with physicians and medical staff

• Created a vaccination messaging system using previous paper records and message alerts with Nextgen system PUBLISHED RESEARCH

● Campbell, S. M., Glisson, W. B., Loeser, D. L., Campbell, A. A. (2015). Have We Left The Barn Door Open? An exploratory examination of data security in consumer grade bio-monitoring devices. Proceedings of the 2015 Southeast Decision Sciences Institute Conference.

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