Meredith B. Vaughn

** *. **** ****** *********, PA 18104

Home :610-***-**** / Mobile :919-***-****

ace3qv@r.postjobfree.com

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