Matthew J.

Homa
4426 Schlegel Avenue
Bethlehem, PA 18020
724.594.7130
mha99072@westpost.net
Career Profile
Confident, dependable management professional with extensive and
diverse experience in the areas of project and personnel management,
equipment management, and training and development. Excellent
organizational, research, analytical, and problem solving skills.
Innate ability to develop loyal and cohesive teams dedicated to the
task at hand.
Experience
3/07-present B. Braun Medical, Inc.

1/09-present Senior Regulatory Affairs Analyst Allentown, PA

* Prepare, write and submit 510(k) submissions and Medical Device
Listings with FDA.
* Prepare, write and submit Class II and Class III Medical Device
Licenses to Health Canada.
* Act as the lead on sustaining and expanding current infusion pump
line which includes managing FDA submissions and serving as the
expert on new product attributes.
* Responsible for overseeing and updating technical files for 220
products to include product specifications, testing history, risk
analyses, regulatory labels, and clinical summaries.
* Research and interpret new Medical Device Directives and apply
findings to existing products currently marketed in Europe. Make
recommendations for required product and label changes based on
regulatory guidelines.
* Integral role in the creation and approval of a new standard
operating procedure for the marketing of products in the European
Union.
3/07-1/09 Regulatory Affairs Analyst Allentown, PA

* Reviewed regulatory status of external customers' and products to

ensure both were in good standing with the appropriate regulatory
agency. Provided direction to the Purchased Finished Goods team
based on findings and provided additional regulatory input.
* Collaborated with representatives of foreign countries to ensure
the seamless registration of drugs and devices in the US, Canada,
and Europe.
* Reviewed internal device labels to ensure compliance with FDA,
Health Canada, and European Union regulations.
7/06-2/07 PharmaCare
Customer Service Representative Pittsburgh, PA
* Resolved billing issues, claim rejections, issued prior
 authorization codes, processed refill requests, and provided plan
parameters for members, pharmacists, and doctors.
* Conducted research to ensure member requests and issues were
properly resolved.
* Mentored trainees and junior representatives, performed special
projects, and helped with trouble shooting issues.
8/04-5/05 Gwinnett County Public Schools - Maxwell High School of
Technology
Paraprofessional Lawrenceville, GA
* Responsible for ensuring that the needs of special education
students were met according to the Individual Educational Plan.
* Supervised and assisted special education students in day to day
activities up to and including comprehension and completion of lab
work.
* Assisted instructor in developing and implementing lesson plans.
Experience Continued
* Worked hands on with students in the lab to ensure that safety
standards and personal work habits were maintained.
* Member of the Public Relations Committee and also SACS Action Plan
Committee.
* Provided support to lead instructor on matters of discipline and
classroom management.
5/02-10/03 United States Army - Second Lieutenant
9/03-10/03 Platoon Leader Iraq
* Trained armor crewmen on mounted and dismounted patrols, building
searches, checkpoint operations, and individual searches.
* Directed convoy escort of multiple vehicles to destinations on
combat missions.
* Executed combat missions focused on route clearance in order to
allow safe passage of friendly forces and to earn the respect and
gratitude of Iraqi citizens.
* Supervised and interacted with Iraqi civilians in close work
environment.
1/03-9/03 Platoon Leader Fort Riley, KS

* Instructed 16-man platoon on tactical situations such as

formations and battle drills.
* Acquired tactical and technical expertise on all aspects of
mounted armor warfare.
* Maintained four M1A1 Main Battle Tanks and equipment totaling over
$16 million.
* Served as Arms Room Officer accountable for weapons and sensitive
items. Implemented weapons card system to improve issue and return
of weapons.
* Served as Company Master Driver and alternate Battalion Master
Driver responsible for ensuring proper training, documentation,
and licenses for all soldiers and vehicles. Developed a new
recording system to ensure all documentation was up to date and
secure.
5/02-12/02 Instructor, Digital Masters Training Course Fort Knox, KY
 * Received initial training as an armor platoon leader including
class work, hands-on training, and field exercises.
* Taught multiple courses on the Force XXI Battlefield Command
Brigade computer system to 100+ students who ranged in rank from
Private to Colonel.
Specialized Training
* Project Team Leadership, American Management Association
* Business Writing and Communication
Education
Bachelor of Arts in History, May 2002
Indiana University of Pennsylvania
Reserves Officer Training Corps 1998-2002
Member of Rho Tau Chi (ROTC Service Fraternity) 1999-2002

Affiliations
Regulatory Affairs Professional Society 2007-2010
Technical Skills
Microsoft Office (Excel, PowerPoint, Word), Outlook, Lotus Notes,
Documentum, SAP.
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