Product Monitoring Specialist

SeaSpine Carlsbad, CA
The Product Monitoring Specialist is responsible for receiving and documenting complaints and support of other product monitoring duties. Product Monitoring Specialist will also ensure that all product monitoring activities are evaluated and investigated by the appropriate individuals in a timely manner.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

* Receive and enter complaints into the Complaint Handling system. Ensure all required information is available and accurately recorded.

* Responsible for obtaining additional information from reporting entities as required, and ensure timely closure of complaints.

* Route complaints to appropriate personnel for investigation.

* Evaluate complaints for reportability determination and help to ensure timely reporting to regulatory agencies, US and international.

* Assist Complaint Investigator in the progress of investigations by providing device history information, analyzing historical complaint data and other preparation activities as assigned.

* Support other post market compliance activities such as recalls and field actions, product safety notifications, adverse event reporting, returned product coordination, etc.

* Maintain complaint records with supporting data, reports, and details, pertaining to the complaint.

* Support generation of queries, data analysis, complaint trending, summary reporting, etc.

* Perform other duties assigned by the Product Monitoring Supervisor.

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