US-MA: Berlin-Senior Post Market Specialist
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Job Title: Senior 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: Senior Post Market Specialist
The Senior Post Market Specialist will: sustain product complaint activities for the Endosurgery Complaint Management Center (CMC) Sustain product complaint activities for the Endosurgery Complaint Management Center (CMC), 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, provide subject matter expertise to CMC Specialist I/II personnel involved in the complaint handling processes and workstreams. The key responsibilities for this position are: MDR assessments for all assigned products, accountable for owning and managing, thorough and accurate complaint records, as well as timely closure of complaint files, 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 and complete projects, as assigned, provide CMC leadership, as required. Qualifications include: 4 year college degree preferred, hands-on 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, must be self-motivated, goal-driven and results-oriented; must be able to perform with limited guidance and direction, demonstrated leadership abilities, strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook); presentation applications such as Powerpoint and/or database applications such as Microsoft Access are a plus and excellent written and verbal communication skills are essential.
Please refer to Job code SD5542 when responding to this ad.
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