Manager of Post Market Surveillance
ZOLL Medical Corporation
• Manage, develop, and mentor department personnel.
• Ensure reporting requirements are compliant with ZOLL Policy in accordance with applicable laws
and regulations worldwide.
• Establish and maintain department metrics that compliment ZOLL goals, targets, and objectives.
• Establish and encourage dynamic communication within all facets of ZOLL related to an effective Post Market Surveillance program.
• Manage and oversee department budget.
• Develop an atmosphere to encourage, motivate, and promote growth opportunity.
• Oversee, support, and maintain compliance with disposition and reporting activities world-wide (i.e., Japan, China, etc...)
• Maintains active communication with Authorized Representative(s), and Notified Body as required.
• Provides support for annual reporting, CER’s, and PMA activities related to Post Market Surveillance.
• Stay appraised of latest developments in the regulatory landscape related to Post Market Surveillance
• Maintain Quality Management System procedures related to applicable Post Market Surveillance responsibilities and promote continuous improvement.
• Capable of managing people at different levels.
• Excellent verbal & written communication skills.
• Proficient with FDA QSR, ISO13485, MDD, EU MDR, and ISO14971 for Medical Devices.