Sr. Post Market Specialist

SeaSpine Carlsbad, CA
The Sr. Post Market Specialist is responsible for receiving and documenting complaints and support of other post market activities including HHE, Recall, Post Market Surveillance and Risk Management. Sr. Post Market 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.

* Perform failure analysis and root cause investigation on returned products including review of Risk Management files and Device History Records.

* 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.

* Update Risk Management documentation with post market data

* Prepare Health Hazard Evaluations to analyze potential field product issues.

* Coordinate recall activities if required.

* Provide trend information to Post Market Surveillance process,

* Define process improvements and implement solutions to improve the efficiency of post market activities.

* Collaborate with other supporting departments in the resolution of quality problems using established problem-solving methodologies determining root cause and driving corrective and preventive actions where required.

* Perform all other duties assigned by the Product Monitoring Supervisor.