Subject Matter Expert - Fda

HeiTech Services is dedicated to attracting highly skilled and motivated professionals. We value our employees. We offer our employees challenging opportunities that facilitate professional growth and development while also providing the support you need to succeed. We are committed to your success because we understand that our employees are the driving force behind HeiTech Services' continued growth.

About the Role:

The Subject Matter Expert (SME) is responsible for responding to inquiries and processing incoming submissions in support of our contract with the Food and Drug Administration (FDA). The SME is expected to use multiple systems, follow standard operating procedures (SOPs) and job aids, research/investigate, and analyze incoming information in order to process the incoming submissions.

Security Clearance: Must possess or be able to obtain FDA federal public trust clearance.

Essential Duties and Responsibilities:

• 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.
• Resolve 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 works 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 requests 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 Skills and Abilities:

• Must be proficient with office automation tools such as Adobe Acrobat Pro and other common Microsoft Windows and Microsoft Office Suite desktop applications.
• Must have thorough organizational skills, analytical skills, and an astute attention to detail.
• Must possess excellent verbal and written communication skills.
• Must be able to work in a fast-paced electronic production environment.
• Must possess or be able to obtain and maintain a Government Public Trust Security Clearance.

Minimum Education and Experience Required:

• Bachelor's degree and at least 3 years' experience in a bioscience 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 file plans for records management.
  

HeiTech Services is an Equal Opportunity/Affirmative Action Employer. All qualified Applicants will receive consideration for employment without regard to race, color, national origin, sex, religion, age, sexual orientation, disability or veteran status.