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Regulatory and Purchasing assistant

Exton, PA
November 26, 2018

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Kathleen A. Rice

**** * **** ***** ***** Exton, PA 19341

(c) 610-***-****

Capabilities Overview

Medical device professional with three years experience in regulatory compliance, purchasing and marketing. My recent work history includes MDSAP certification preparedness, Quality Management System analysis, supplier management and purchasing processes. Efficient, organized and responsive. Strengths include:

ISO 13485: 2016 and 21 CFR 820

Data Entry

Internal audits

MDSAP Transition

Purchase Orders

Document Control

Time Management and Prioritizing

Inventory Management

Significant Accomplishments

Certified auditor of ISO 13485:2003

Assisted MDSAP gap analysis in preparation for a external audit

Conducted external audits for two of our suppliers

Edited controlled document drafts for revision

Maintained device history records for hundreds of custom sterile surgical instrument kits

Maintained supplier files with regulatory compliance documentation and quality agreements

Promoted compliance with Quality Management System

Conducted physical and electronic inventory maintenance of surgical supplies

Processed over 1200 purchase orders per year from buying reports

Professional Experience

Sklar Instruments, West Chester PA

Purchasing, Regulatory and Marketing Assistant 2015 to current

Support the materials management, regulatory and marketing teams in the expansion and development of new product lines, execution of purchasing functions, quality management system compliance (ISO 13485), market research and supplier development

CNB Research & Consulting LLC, Chester Springs, PA

Data and Reports Associate 1995 - 2015

Combined innovative tools, proven research methods and hands-on, strategic marketing experience to deliver insights and opportunities across the entire product life cycle

Lionville Community YMCA, Exton PA

Welcome Center Associate 1996 - 2014

Supported the mission and goals of a non-profit wellness and childcare facility via administrative duties, reception, customer service, data management, event promotion and blood drive coordinator.

Education / Training

Springhouse Education & Consulting, Exton PA

Software Training and Career Development Program 2014

Intermediate to advanced MS Office applications, effective business writing, also beginner Adobe suite, Visio, SharePoint

University of New Hampshire, Durham NH

B.A., Communications


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