GARY BAKER

P.O. Box15084
Austin, TX 78761
574-275-1137
gbake21152@icloud.com
SUMMARY
I have a masters degree in public administration with a concentration in health care administration and policy.
I have over 11 years of experience working in the corporate environment where I provided regulatory support for orthopedic
medical devices, including managing medical device clinical trials and writing pre-market medical device submissions for
review by the U.S. Food and Drug Administration, Health Canada and the European Union.
I have over 24 years of public service experience as a paramedic and member of the Kosciusko County Hazardous Materials
Response Team as well as a volunteer fireman with the Warsaw Fire Department.
SKILLS / EXPERIENCE
REGULATORY EXPERIENCE:
Regulatory subject matter expert for new product development in collaboration with Research and Development,
Marketing and Commercialization and Project Management.
Planning and implementation of regulatory strategies and activities for product development. This included review of
mechanical test protocols and test reports.
Compilation, organization and authorship of submissions to regulatory agencies for marketing authorization. This
includes submissions to the U.S. Food and Drug Administration, Health Canada and the European Union.
Marketing materials and product labeling review and approval to comply with regulatory requirements and appropriate
claims language.
Development and Review of Standard Operating Procedures (SOPs) associated with regulatory or clinical functions.
Direct interface with regulatory agency personnel regarding the marketing authorization for medical devices, or other
regulatory matters that developed.
Regulatory Affairs Professionals Society (RAPS) membership from 2003 to 2014.
Regulatory Affairs Certification (RAC) U.S. from 2005 2014 (currently inactive)
MICROSOFT OFFICE PROFICIENCY:
Word:
I can create, edit, format and lay out word documents. I can edit and manipulate text, insert images or graphics, add
mailings and references and work with tables. (This resume is in a table format)
Excel:
I can format, create, edit and lay out Excel spreadsheets. I can isolate data and create graphs or charts from that data. I
can copy and transfer data between spreadsheets. I can use formulas to make the data meaningful.
PowerPoint:
I can create edit format and lay out PowerPoint presentations. I can add or edit text, images, or graphs etc. I can set up
a complete PowerPoint presentation and set it to run automatically.
DATABASE PROFICIENCY:
Through my own initiative I took the time to learn how to work in an antiquated database (MedLog). When I left

Biomet I was the only employee that was able to successfully extract data from MedLog into a usable report format.
I was asked to work on and eventually manage the implementation of a global database system that would incorporate
all of the current local databases into one system under a single global structure. Once all of the databases were
identified and the functionalities mapped, I was removed from the project and it was given to one of the European
regulatory personnel so that the image of a global database structure could be maintained.
CLINICAL RESEARCH:
I took over management of the Total Temporomandibular Joint medical device clinical trial for subsidiary Walter
Lorenz Surgical. I successfully closed that clinical trial and assisted in the drafting of the Premarket Approval
application to get the product approved by the U.S. Food and Drug Administration. This introduced the only off the
shelf TMJ joint replacement prostheses in the United States.
I took over management of the ComPliant PreStress (ComPress) medical device clinical trial. This device introduced a
novel technology for the treatment of limb salvage procedures to treat osteosarcoma of the distal femur. I successfully
closed that clinical trial and authored the Premarket Notification submission to get the product clearance by the U.S.
Food and Drug Administration.
I initiated the clinical study for the Biomet Rotating Platform mobile bearing knee replacement system. This included
creating the study protocol and the case report forms, collecting and verifying the data collected, as well as data entry
and verification. I released this clinical study to one of the clinical affairs specialists when I transferred back to
regulatory affairs.
EMERGENCY MEDICAL CARE
Paramedic:
Pre-hospital diagnosis and treatment of medical emergencies for the sick and/or injured. I developed an easy method
for understanding the bicarbonate buffer system and acid/base balance as it pertained to prehospital emergency
medical care.
Advanced Cardiac Life Support (ACLS):
Specialized training in the diagnosis and prompt treatment of potentially life threatening cardiac anomalies.
Basic Trauma Life Support (BTLS):
Specialized training in the prompt evaluation and treatment of life threatening injuries.
CPR:
Certified CPR Instructor by the American Red Cross.
WORK HISTORY

BIOMET ORTHOPEDICS INC.

56 East Bell Drive
Warsaw, Indiana 46582
Dates

1 October, 2002 21 August, 2014

Job Title
Job
Description

Senior Regulatory Affairs Specialist

Provide regulatory subject matter expertise through collaboration with multiple cross functional teams
including Research and Development, Marketing and Commercialization and Project Management to
ensure regulatory compliance.
Plan and implement regulatory strategies and activities for product development from concept to full
commercial market release.
Compilation, organization and authorship of submissions to regulatory agencies for marketing
authorization.
Maintain regulatory subject matter expertise through continuous monitoring and review of changes in
regulatory policy or regulatory interpretation of associated government agencies.
Regulatory review of marketing materials and product labeling.
Review of proposed design changes to products on the market and implementation of any regulatory
documentation required.
Development and/or review of Standard Operating Procedures associated with regulatory functions.

MULTI-TOWNSHIP EMS INC.

2304 East Center St.
Warsaw, Indiana 46580
Dates

1 November 1980 1 April 2004

Job Title
Job
Description

Emergency Paramedic
Provide Pre-hospital diagnosis and treatment of medical emergencies for the sick and/or injured.

PROFESSIONAL ACHIEVEMENTS

REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS)

Member of the RAPS Ethics Committee 2007 2008
Chair of the RAPS Ethics Committee 2008
Contributed introductory chapter to the first online course in Regulatory Ethics for RAPS
EMERGENCY PARAMEDIC
Named Paramedic / EMT of the Year in 2001
Paramedic representative to the hospital paramedic medical review committee from its
inception until the day of my retirement from EMS.
EDUCATION
INDIANA UNIVERSITY PURDUE UNIVERSITY FT. WAYNE
MASTER OF SCIENCE PUBLIC ADMINISTRATION GRADUATED 2002
Graduate GPA 3.857 (Transcript available upon request)
HONORS:
Named to the National Deans List
Named to Whos Who in American Colleges and universities
PI ALPHA ALPHA Honor Society
PHI KAPPA PHI Honor Society
REFERENCES
MARY VERSTYNEN
Director, Regulatory Affairs Biomet (Retired)
260-483-0823
PAUL SLAGLE
Development Engineer Biomet Orthopedics
paul.slagle@biomet.com
260-414-2646
KRISTIN PRIOR
Field Services Director Agency of Human Services State of Vermont
kristin.prior@state.vt.us
802-343-6222
ROBERT WOLFE
Retired
wolfe_robert@yahoo.com
630-235-1017