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Job Title:     Principal Post Market Specialist
Job Location:  MA: Berlin
Pay Rate:      Open
Job Length:    full time
Start Date:    2008-05-15

Company Name:  The Cambridge Group Ltd.
Contact:       Stephanie Oscar
Phone:         E-mail or fax only
Fax:           203-226-3856

Description:   Principal Post Market Specialist

The purpose to the Principal Post Market Specialist will be to assist the Endosurgery Complaint Management Center (CMC) functional management in the day-to-day operations of medical device complaint processing, ensure complaint handling tasks are completed as required by company policies and procedures, as well as compliant with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485-2003, etc.), manage product complaint volumes and/or complexities commensurate for a Senior-level Specialist, identify & implement CMC workstream improvements to increase the effectiveness, integrity, and/or timely management of complaint files and provide subject matter expertise to CMC Specialist I/II personnel involved in the complaint handling processes and workstreams. The key responsibilities to this position are: to ensure complaint records, MedWatch reports (FDA Form 3500A), and applicable complaint handling documents are compliant with Good Documentation Practices (GDP), complete mandatory training by established due dates, maintain accurate and current training records at all times, partner with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned product, professional contact with customers to gain insight into each complaint event, prepare and submit FDA MedWatch and Baseline reports within the mandated timelines, periodic review (audit) of closed complaint files for thoroughness and accuracy, complete projects, as assigned and provide CMC leadership, as required.  The qualifications are: 4 year college degree preferred, extensive hands-on experience as a CMC Specialist, or other similar experience in medical device complaint handling, familiarity with medical device terminology as well as anatomical and physiological terminology is required, direct experience in writing and filing MedWatch reports, demonstrated experience as a leader, must be self-motivated, goal-driven and results-oriented; must be able to perform with minimal supervision, strong proficiency in common personal computer applications such as Microsoft Office (Excel, Word, Outlook, and Powerpoint); database applications such as Microsoft Access is a plus and excellent written and verbal communication skills are essential

Please refer to Job code SD5543 when responding to this ad.

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