Premarket / Postmarket Tracking Services Subject Matter Expert

Summary of Responsibilities :

The Subject Matter Expert (SME) is responsible for responding to inquiries and processing incoming submissions in support of our customer, the Food and Drug Administration (FDA). The position is expected to use multiplesystems, follow standard operating procedures (SOP's) and job aids,research/investigate and analyze the incoming information in order to process the incoming submissions.

Essential Job Functions:

·        Interpret guides and manuals for processing incoming requests with numerous steps and sequences.

·        Instructing the medical device community on sending in regulatory submissions and compiling data for the client.

·        Resolves problems submitted by the medical device industry by analyzing issues, choosing appropriate methods to address the problems and making the necessary adjustments.

·        Compiles data and work through issues with the internal FDA client by devising procedures or creating new processes to remedy various situations related to regulatory submissions.

·        Analyze to ensure that the device is within the CDRH jurisdiction, that there is adequate information to proceed, whether a high priority allegation has been identified, time sensitive topics and whether a defined impact working rule applies. 

·        Investigate the request to validate the information and provide supporting sources to the request.

·        Create request using several different applications. Be able to summarize from several different sources what the request is.

·        Analyze and respond accordingly to incoming voicemails.

·        Research the request and various websites to determine the correct product code.

·        Manage allegation inbox, official correspondence and action emails.

·        Analyzing provided documents to ensure that all required information has been provided.

Follow up with correspondent for any missing information.


Required Qualifications:

·        Bachelor’s degree; and at least 3 years’ experience in a bio science or records management related field

·        Ability to abstract data from biologic applications into an Oracle or Access database and verify data or data entry or the ability to develop and implement new fileplans for records management

Skills and Abilities Required:

·        Proficient with office automation tools such as Adobe Acrobat Pro and other common Microsoft Windows and Microsoft Office Suite desktop applications.

·        Thorough organizational skills, analytical skills and an astute attention to detail.

·        Possess excellent verbal and written communication skills.

·        Must be able to work in a fast-paced electronic production environment.

Possess or be able to obtain and maintain a Government Public Trust Security Clearance.


Email resume with job code