Medical Design
Resume:
Meché
Carlos
Ragland
RESEARCH,
REGULATORY
AFFAIRS,
&
DATA
ANALYST
Crossing,
Cincinnati,
Ohio.
45231
-
Mobile
(513)
886-
–
Home
(513)
521-
4964
–
***********@*****.***
Career
Objective
Resourceful, highly competent professional, with comprehensive
experience in laboratory research, regulatory affairs, and
biostatistics. Strong analytical skills, with outstanding abilities in
strategic planning, problem solving, decision making, time
management and communications. Adept working with scientific and
medical data, experienced in product testing, analytical techniques,
and regulatory guidelines set by FDA. Strong work ethic, initiative
and self-motivations skills, seeking position in R&D, or Regulatory
Affairs.
Experience
Regulatory
and
Quality
Assurance
Specialist
(Contract)
Integra
LifeSciences,
Medical
Devices
2013
-
Present
• Review
promotional
material
and
device
labeling
for
regulatory
compliance.
• Submit
country
applications/submissions
for
approval
to
market
safe
and
effective
Medical
Devices.
• Preparing
documents
for
global
registrations,
this
includes
labels,
apostilles,
PMA,
510K
FDA
submissions,
CE
mark
strategies
and
global
device
development
and
market
approval.
• Determine
where
device
design
or
process
changes
occur
whether
and
how
regulatory
agencies
need
to
be
informed
and
provide
appropriate
documentation.
• Assist
with
updating
Technical
Files,
and
Design
Dossiers
for
Medical
Device
Products.
• Work
with
Quality
to
assure
development
of
a
design
history
files.
• Submission
of
Medical
Device
Reports
(FDA
Form
3500A),
trend
analyses
and
complaint
closure.
Regulatory
Data
Specialist
(Contract)
Procter
&
Gamble
Beauty,
Health,
&
Hair
Care
2010
-
2013
• Assisting
the
Data
Management
team
in
the
planning
and
preparation
of
regulatory
reviews.
• Participated
in
training
employees
and
developing
SOP's
for
quality
practices
applicable
to
the
design
and
production
of
raw
materials
from
contracted
manufactures.
• Reviewing
and
classifying
safety
and/or
regulatory
compliance
related
to
documents
submitted
from
suppliers
and
manufactures,
including
MSDS,
CoA,
Raw
Material
Data
Sheets,
BSE,
and
others.
• Preparing
documents
to
enable
the
premarket
and
continuing
clearance
of
Beauty
&
Health
Care
products
in
the
countries
in
which
the
company
conducts
its
business.
• Global
raw
material
reviews
for
EMEA,
ASIA,
LA,
US,
and
Canada.
Meché
Carlos
Ragland
Laboratory
Technician/Formulation
(Contract)
Procter
&
Gamble
Fragrance,
Fabric,
&
Home
Care
June
-
2010
• Formulate
various
types
of
Fragrance,
Home
Care,
Skin
Care
and
Sun
Care
products
including
but
not
limited
to
fine
fragrance,
creams,
lotions,
balms,
sprayable
lotions
and
surfactant
based
systems.
• Assure
compliance
with
GMPs
and
FDA
requirements.
• Review
formulas
and
raw
materials
for
compliance
with
regulatory
Guidelines.
• Keep
current
with
new
ingredients
and
technologies
and
recommend
new
materials
and
techniques
when
appropriate.
Web
Designer
&
Developer
Media
Bridges
Cincinnati
2003
-
2009
• Work
directly
with
Executive
Director,
Director
of
Operations
and
Educational
staff
to
design
creatives
based
on
organization
needs..
• Assist
in
creating
branding
guidelines
and
enforce
standards
on
for
local
media
outlets.
• Design
creatives
for
the
web,
newsletters,
advertisement
banners,
and
print.
• Assist
in
teaching
web
and
multimedia
classes
to
the
community
as
part
of
organizations
outreach
and
educational
goals.
Competencies
Regulatory,
R&D,
and
QA
Knowledge
of
cosmetic/personal
care
raw
materials,
functionality,
and
interactions.
Understanding
of
emulsion
and
surfactant
technology
as
well
as
general
formulation
techniques.
In-
depth
understanding
of
the
principles
of
GCP,
GMP,
and
GLP
and
regulatory
submissions.
The
ability
to
track
and
report
data,
in
order
to
monitor
adherence
to
regulatory,
data
configuration
and
contractual
requirements;
conduct
audits
and
reviews
to
ensure
products
meet
requirements.Provide
regulatory
guidance
to
promote
ingredient
and
formula
attributes
of
new
and
existing
products
by
building
compositions
for
product
packaging
and
labels.
Ability
to
assist
with
formulation
ceation,
wet
bench
work,
analytical
analysis
and
stability
testing
with
use
of
HPLC,
Gas
Chromatography
&
Mass
Spectrometry,
Specific
Gravity,
and
Sensory
Evaluation
testing.
Also
GLP,
and
record
keeping
abilities
and
experience
maintaing
lab
safety
&
supplies.
Meché
Carlos
Ragland
Biostatistics
The
ability
to
provide
statistical
support
for
routine
projects.
Perform
data
analysis,
statistical
experimental
design,
sample
size
determination,
and
other
appropriate
applications
of
statistical
methods
in
support
of
product
development,
clinical
studies,
manufacturing
activities,
and
product
quality.
Apply
current
statistical
methods
with
use
of
SPSS,
STATA,
and
some
R
programming
knowledge.
Business
and
Web
Applications
Proficient
in
MS
Office
suite
with
use
of
Excel
for
data
analysis
and
Visio
for
drawing
and
diagraming.
Experience
with
Adobe
Creative
Suite
for
web
development
and
design,
as
well
as
basic
HTML
5
and
CSS.
Ability
to
use
Adobe
Acrobat
to
create
and
manipulate
documents
for
electronic,
submission
and
the
implementation
of
product
dossiers.
Basic
SAP
ERP
for
raw
material
tracking
and
analytics.
Education
University
of
Florida
College
of
Pharmaceutical
Outcomes
&
Policy
Currently
pursuing
MS
Drug
Regulatory
Affairs
&
Policy,
online
Drexel
University/
University
of
Cincinnati
Degree:
2011
Bachelors
of
Science
in
Psychology
with
a
minor
in
Neuroscience
Certificate:
Regulatory
Affairs
&
Biostatistics,
UCSD
online
References:
Available
by
request
Meché
Carlos
Ragland
Contact this candidate