Clinical Researcher with Regulatory Affairs Medical Device Experience

Job Target: Regulatory Affairs Position
Employment Status: Employed - Actively Looking
Experience Level: Entry Level
Seeking: Full-Time
Industry: Research Resumes

Salary:
Degree: Master's Degree (MA/MS/MBA)
Security Clearance: None
Travel: Moderate
Relocate:: Yes

Objective

Seeking a challenging clinical research position, where my regulatory affairs and clinical research knowledge can be applied and utilized in an environment that fosters learning new concepts and expanding upon my existing knowledge.

Job Target

Regulatory Affairs Position

Professional Experience

2011 – present	bioMerieux, Inc. Regulatory Affairs Intern	Durham, NC, USA
	-Prepare international regulatory submissions to support global product registration [CE marking design dossiers and technical document files] -Prepare document packages for regulatory submissions to FDA [PMA supplements, regulatory strategies, 510(k)s, pre-IDEs] -Maintain current information of device and drug regulations, guidance documents, and standards applicable to device products and convey to appropriate departments when applicable -Manage and maintain regulatory standard compliance to products -Review and approve documents for accuracy and completeness -Active role in project management scope -Ensure that all regulatory activities are in compliance with the latest regulatory guidelines -Collaborate closely with all departments during all phases of the project -Correspond with regulatory agencies
2009 – 2010	North Carolina Divison of Medical Assistance Research Specialist	Raleigh, NC, USA
	-Provided assistance to outside pharmacies with Medicaid recipient lock-ins, medication overrides, and questions pertaining to recipients’ benefit status -Researched Medicaid recipients’ pharmacy & ancillary medical history and cases, on an individual patient basis -Provided support for the Chief of Pharmacy & Ancillary -Supported Pharmacy & Ancillary department -Offered additional support with the North Carolina Division of Medical Equipment
2008 – 2008	Challenging Horizons Program At-Risk Youth Counselor	Columbia, SC, USA
	-Involved with innovative, service-learning experiences that met important community needs -Implemented therapeutic, behavior interventions at an after-school program for at-risk middle school aged students with behavioral, emotional, and learning disabilities in rural South Carolina -Counseling experience led to an Independent Research Study, in regards to the disclosure effect and journaling in at-risk youth

Education

2011	Campbell Univseristy Clinical Research – Master's Degree (MA/MS/MBA)	Buies Creek, NC, USA
	-Expected graduation date: 15 Dec. 2011
2008	University of South Carolina Experimental Psychology – Bachelor's Degree (BA/BS)	Columbia, SC, USA

2008	University of Valladolid Spanish – Not Specified	Valladolid, Spain
	-Certificate degree program
2006	Wake Technical Community College General – Associate or Vocational Degree (AA/AS/MCSE/etc.)	Raleigh, NC, USA

Relocation Preferences

Any location.