Premarket / Postmarket Tracking Services Subject Matter Expert Jobs

PN Automation, Inc

Location:
United States, Landover, MD

Category:
Public Sector

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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.

Job Responsibility:

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

Requirements:

Bachelor’s degree
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
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

Additional Information:

Job Posted:
December 11, 2025

Employment Type:

Fulltime

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Premarket / Postmarket Tracking Services Subject Matter Expert