Surveillance Operations Manager jobs in Lowell, MA

Essential Functions:

• 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.

Skills Requirements:

• 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.