Manager of Post Market Surveillance

Location: Chelmsford, MA, United States of America

Resuscitation

Responsible for managing Post Market Surveillance Activities for ZOLL Medical Corporation, specifically domestic and international reporting, Review and Evaluation of customer communication for complaint designation and reportability, Inquiry responses to Competent Authorities, Device Tracking, Field Safety Corrective Action, and Device Corrective Action activity. Reports to the Senior Director of Quality Assurance. Works closely with Regulatory Affairs related to Post Market Surveillance, product maintenance, and registration.

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.