To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02746

About our client Our client is a leading medical device company, which is focused in the development and commercialization of less invasive medical devices and procedures. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance (Post-Marketing Specialist) Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform MDR assessments for all assigned products 2) Handle, own and manage complaint record (thoroughly and accurately) as well as timely closure of complaint files 3) Ensure that complaint records, MedWatch reports (FDA Form 3500A) and applicable complaint-handling documents are compliant with Good Documentation Practices (GDP) 4) Complete mandatory training by established due dates 5) Maintain accurate and current training records (at all times) 6) Partner with Complaint Investigation Sites (CIS) to ensure thorough and timely investigation reports for returned products 7) Maintain professional contact with customers to gain insight into each complaint event 8) Prepare and submit FDA MedWatch and Baseline reports within the mandated timelines 9) Sustain product complaint activities for the endosurgery Complaint Management Center (CMC) 10) Ensure that complaint-handling tasks are completed as required by company policies and procedures, as well as are compliant with applicable industry regulations (FDA 21 CFR Part 820.198, FDA 21 CFR Part 803, ISO 13485-2003, etc.) 11) Manage product complaint volumes and/or complexities commensurate with the position 12) Identify and implement CMC work-stream improvements to increase the effectiveness, integrity and/or timely management of complaint files 13) Provide subject matter expertise to CMC Specialist I or II personnel involved in the complaint-handling processes and work-streams 14) Complete projects (as assigned) 15) Provide CMC leadership Requirements 1) Degree (4 year) preferred 2) Hands-on experience in handling complaints related to medical devices 3) Experience in writing and filing MedWatch reports 4) Experience in presenting applications (PowerPoint) and/or database applications (Microsoft Access) a plus 5) Knowledge of medical device, anatomical and physiological terminology 6) In-depth understanding of global regulations 7) Ability to perform with limited guidance and direction 8) Self-motivated, goal-driven and result-oriented approach 9) Superb proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) as well as knowledge of presentation applications (PowerPoint) and/or database applications (Microsoft Access) a plus 10) Excellent leadership skills 11) Superb communication (written and verbal) skills