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MARY L.

JEAN
Oakland Park, Florida 33309 (978) 317-2415 mljean@icloud.com
Stat Medical Devices, Inc., North Miami Beach, FL Director Quality Assurance and Regulatory Affairs (QARA) 08/2005-Present Independent Regulatory Affairs Consultant 03/05 – 08/05 Accomplishments: Brought a new Quality Management System to maturity ensuring continued regulatory compliance to cGMP, ISO 13485 and 93/42/EEC MDD requirements Primary liaison for FDA inspections, Certifying Body, internal and customer audits Responsible for Regulatory Compliance, definition and implementation of Remediation Activities relating to company’s first FDA inspection, and resulting warning letter, achieved closure notification within 10 months Conducted Class II voluntary recall for sterile product, achieved FDA closure within 15 months Authored and submitted 510(k) for Class II sterile product, received SE determination within 90 days Responsibilities: Manage relationships with local regulatory agencies and notified bodies Senior liaison for Technical File audit with the European Notified Body, BSI Author and update Technical Files for Class IIa sterile products Prepare and submit applications for Canadian Medical Device licenses and license amendments Experience in researching regulatory requirements for multiple countries including EU, Canada, and South American, emerging markets Maintain Establishment Registration and Device Listings Conduct continuing surveillance including monitoring MAUDE, MDR, and Recall, databases for potential similarities with company products, Coordinate Management Reviews, report on performance, health, and effectiveness of the QMS Audit vendors for cGMP, ISO 13485:2003, and 93/42/EEC MDD Review, acceptance of Corrective Actions and validation of remedial action plans for internal and vendor nonconformances Develop, and manage customer complaint system, track and trend complaints for developing issues Evaluation of customer complaints, determination of need to file and filing of MDR reports to domestic and international authorities Participate on product development teams ensuring US, EU, Canadian and other international regulatory requirements are incorporated as part of the development process Abbott Laboratories, MediSense Products, Bedford, MA Compliance Specialist, Quality Assurance Regulatory Affairs (QARA) Wrote procedural documents Analyzed all forms of labeling for adherence to 21 CFR 801 and 809 Participated in Division Audits as the training coordinator for QARA Performed Gap Analysis for site and division documents, executed actions to eliminate GAPs Re-structured label approval process, trained labeling originators Co-Developed and taught Training program for site wide Training Coordinators (1999 – 2004) (2000 – 2004)

Administrative Assistant, Consumer Marketing (1999-2000) Developed and maintained database for glucose budget tracking Prepare documents and presentations, generate POs and ACRs as required, track all invoices Maintain calendars for Consumer Marketing personnel, mail distribution, Federal Express and DHL shipments The Davis Temps, Burlington, MA - Abbott Laboratories, MediSense Products, Bedford, MA Kelly Services, Nashua, NH -- Sanders, A Lockheed Martin Company, Nashua, NH (1999) (1997 - 1999)

MARY L. JEAN
Oakland Park, Florida 33309 (978) 317-2415 mljean@icloud.com Page 2
Supported Employee Services Sr. Administrator, Technical Publication Services Department Manager, Facilities Group and Consumer Marketing Group Implemented use of QuickBooks for employee store, processed weekly deposits, accounts payable Monks & Co., Inc., Nashua, NH Pampered Chef, Nashua, NH; Good Stuff Entertainment, Merrimack, NH Office Manager/Administrative Assistant to President Maintained databases, tax records, work schedules, office equipment AR/AP, generated monthly and weekly reports (1995 - 1997) (1994 - 1995)

Raytheon Service Company, Burlington, Sudbury and Bedford, MA Tape Librarian (1983 - 1986) Quality Specialist; Secret Security Clearance (1986 - 1988) Sr. Administrative Assistant; Secret Security Clearance (1989 - 1984) Documented software procedures for (TARP) Warehouse Inventory and Antenna Element Batching Preserved an up and running state for remote sites with nightly upload and download of TARP data Authored user manuals, factory test plans presented to government customers Liaison between management in various Program Management Offices (PMO), and government customers Established, tracked and reported action items and Technical Assistance Requests for PMOs Achieved and maintained "on schedule" state for the delivery of Contract Data Requirements List (CDRL) items Analyzed software design, functional specification reviews and Preliminary Qualification Testing (PQT) Tracked system trouble reports from PQT, design reviews, and software and hardware problem reports Developed and conducted training of civil engineers for Environmental Control Systems Operator Training Tested Environmental Control Systems baseline software Teaching Assignments Special Needs Aid, Nashua Senior High School, Nashua, NH Teacher Reading, Science and Math grades 6-8 Our Lady of Lourdes School, Melbourne, FL Teacher Reading, Saint Joseph School, Nashua, NH Certifications and Appointments ISO 13485:2003 Auditor (ASQ CQA) Florida Notary Organizations Association of Notary Publics American Society of Quality (ASQ) Regulatory Affairs Professional Society (RAPS) Education North Eastern University – Boston, MA (2005) Graduate Certificate Regulatory Affairs Rivier College - Nashua, NH (1976 - 1980) BA Elementary Education References Available upon request 1980 - 1983