Medical Device Project
Resume:
Meredith B. Vaughn
** *. **** ****** *********, PA 18104
Home :610-***-**** / Mobile :919-***-****
************@*****.***
Professional Experience:
Valeant Pharmaceutical Bridgewater, NJ
Regulatory Documentation Specialist; Contractor on behalf of Kelly
Scientific
Archivist for a library of Regulatory submissions, promotional &
advertising materials.
3/2013-8/2013
DePuy Synthes West Chester, PA
Regulatory Recall Specialist; Consultant on behalf of Maetrics
Consultant for the Recall/Field Action remediation project for all product
divisions at DePuy Synthes. This project entailed exposure to HHE
evaluations, through and including the execution of the Recall and monthly
FDA reporting/closure.
11/2012-3/2013
B.Braun Medical Allentown, PA
Regulatory Analyst; Contractor on behalf of Allied Personnel
Responsibility as the point of contact for Customer Requests for clients
that we OEM, or contract manufacture product for to receive FDA/Other
Government agency information so as to clear their devices that we export.
5/2012- 9/2012
bioM rieux Durham, NC
Quality Specialist; Contractor on behalf of Kelly Scientific
bioM rieux is an In- vitro diagnostic manufacturer, developing medical
device, software, and reagents utilized for healthcare as well as product
safety.
. Aftermarket assignments handled by the Commercial Operations Quality
Dept.
1) Field Actions comprised of customer notifications on product
safety alerts, Software upgrades, and product destruction requests.
2) Complaint trending handled on a monthly basis to establish if
CAPA process is being implemented and followed.
3) LCR's (Labeling Change requests) generated out of Field Actions
requires rework of IFU's, safety labeling.
8/2010- 10/2011
Teleflex Research Triangle Park, NC
Regulatory Affairs Specialist; Consultant on behalf of MedPoint Consulting,
LLC.
Teleflex Medical remains a competitive device manufacture with a large
market hold on the Catheter, Respiratory/Pulmonary product lines.
. Responsibility as the Database Administrator for the Teleflex US
product database classification project; entailed researching product
lines comprised of Respiratory, Urology, Suture, and Surgical to
ensure that proper FDA and MDD classifications were given to all
twenty-four thousand products. The compiled database ultimately allows
for an upload into an ERP system at some later date.
. Supplied accurate FDA product classification information to the
Customs Import/Export Compliance team to ensure that Teleflex product
lines cleared all Customs/Brokerage houses.
. Assigned GMDN codes to product families being registered into
Australia, and the EU
. Point of contact for Teleflex US requirements to aide our Authorized
Rep in pursuit of registration into the United Arab Emirates.
. Daily activities conducted out of Excel, and Outlook email
applications.
5/2008- 7/2009
Imaging Sciences International, LLC. Hatfield,
Pennsylvania
Regulatory Affairs Specialist
ISI, LLC. is owned by Danaher Corporation. A pioneer of the Dental 3D Cone
beam imaging machines utilized by dental practitioners in the diagnosis and
treatment plan to such conditions as TMJ.
. Registered 3D Cone beam imaging product lines into the International
markets, with focus to the Asia Pacific, and Latin American lands.
. Developed and wrote clear arguments and explanations for new product
licenses and license renewals.
. Reviewed complaints escalated to Regulatory attention to determine
reportability and file MDR/Vigilance reports when deemed necessary.
. Aided in Recall/Removal efforts of necessary units in the field.
. Ensured that the company's products comply with the US Food and Drug
Administration (FDA), local and state agencies and the International
agencies regulations.
. Keep up to date with international legislation, guidelines and
customer practices.
. Advised engineers and management on regulatory requirements
. Work with project teams and colleagues involved with the development
of new products on regulatory requirements.
. Coordinated all ECN; to address Laser warning label changes that
needed to be affixed to the 3D product line.
. Daily exposure to Microsoft Office applications, such as Excel,
Outlook applications.
10/2004- 5/2008
Aesculap Inc. / Aesculap Implant Systems, Inc. Center
Valley, PA
Regulatory Affairs Coordinator
Aesculap Inc./ Aesculap Implant Systems is the sister Company to B.Braun
Medical, a leading Medical Device manufacture of products that range from
Sutures progressing all the way to such devices Knee Implants, cervical
fixation devices, etc.
. Coordinated and compiled necessary information for inclusion into
510(k), IDE submissions.
. Temporary filled in as the Complaint Coordinator within the RA/QA
group. Handling calls and emails coming in from Salesforce & Hospital
entities advising of issues/potential harm experienced while utilizing
Aesculap products. Escalating necessary complaints to MDR review onto
reportability.
. Reviewed and completed incoming product load sheets for entry into SAP
database.
. Completed Class I/II Regulatory determinations.
. Analyzed data as well as compiled information, for product
registration to ensure early product approval and internal
documentation needed.
. Kept abreast of FDA medical device events through; Gray Sheet, Devices
and Diagnostics Letter, RAPS membership.
. Generated travel requests for the stateside, and international
RA/QA/QM departments.
. Maintained department personnel PTO (paid time off) requests, and
running ledger of time exhausted.
. Entered and tracked expense reports for Director and Managers of RA.
. Advanced exposure to Microsoft Office applications; i.e. Outlook/
Calendars, Excel, PowerPoint, Word, Access, to complete anywhere from
meeting arrangements to presentations for conferences.
Education:
Strayer University Pursuant
Bachelor; B.A
Certification:
April 2007
RAPS Introduction to Regulatory Affairs & the Healthcare Product Life
Cycle
References:
Available upon request
Contact this candidate