Premarket / Postmarket Tracking Services Subject Matter Expert

Pn Automation, Inc.; Landover (MD); On-site; USD 70,000 - 100,000; Full time

Job summary

Pn Automation, Inc. is seeking a Subject Matter Expert to respond to inquiries and process incoming submissions for the FDA, using SOPs and multiple systems.

The role emphasizes research, data analysis, and creating procedures to improve regulatory submissions, with emphasis on CDRH jurisdiction and documentation integrity.

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 develop and implement new fileplans for records management.

Responsibilities

• Interpret guides and manuals for processing incoming requests with numerous steps and sequences.
• Instruct the medical device community on submitting regulatory submissions and compiling data for the client.
• Resolve problems by analyzing issues and selecting appropriate methods to address them and making necessary adjustments.
• Develop procedures or create new processes to remedy situations related to regulatory submissions.
• Ensure device falls under CDRH jurisdiction with adequate information and time-sensitive considerations.
• Validate information and provide supporting sources.
• Create requests using multiple applications and summarize sources.
• Respond to voicemails and research product codes to determine correct actions.
• Manage allegation inbox, official correspondence and action emails.
• Review provided documents to ensure required information is included.

Skills

Data abstraction

Analytical skills

Communication skills

Fast-paced environment

Education

Bachelor’s degree in bioscience or related field

Tools

Adobe Acrobat Pro

Microsoft Office

Job description

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 multiple systems, follow standard operating procedures (SOP's) and job aids, research/investigate and analyze the incoming information in order to process the submissions.

Essential Job Functions

• Interpret guides and manuals for processing incoming requests with numerous steps and sequences.
• Instruct the medical device community on sending in regulatory submissions and compiling data for the client.
• Resolve problems submitted by the medical device industry by analyzing issues, choosing appropriate methods to address the problems and making the necessary adjustments.
• Compile 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.
• Analyze 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 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.

Apply

Email resume with job code PNA-PPTSSME