1. Select the statement that describes how you meet the education and/or experience for this position at the GS-09 level.A. I have at least one year of specialized experience, equivalent to the GS-07 grade level or higher in the Federal service, gathering and organizing registration and listing data pertaining to medical devices and/or radiological products; responding to inquiries on registration and listing compliance policies and procedures; and assisting in the development of briefings and reports on studies of program operations.
2. Select the statement that describes how you meet the education and/or experience for this position at the GS-11 level.A. I have at least one year of specialized experience (equivalent to the GS-09 level in the Federal service) developing and measuring compliance programs covering the registration and listing of medical devices and/or radiological products; conducting studies and statistical analyses on the productivity and effectiveness of programs or work processes; integrating registration and listing data systems; and providing technical guidance on registration and listing law, regulations and guidance.
For each task in the following group, choose the statement from the list below that best describes your experience and/or training. Darken the oval corresponding to that statement in Section 25 of the Qualifications and Availability Form C. Please select only one letter for each item.A- I have not had education, training or experience in performing this task.
3. Evaluate the potential effectiveness of proposed organizations and programs to recommend changes to organizational structures.
4. Gather data from records, computer files, previous studies, and interviews to identify and resolve program issues.
5. Measure productivity and effectiveness of programs to develop briefings and reports for management review.
6. Prepare statistical analyses and other interpretative reports (e.g. Program Oriented Data Systems reports, PMA Foreign Inspection, and Postmarket Surveillance reports).
7. Evaluate field reports for accuracy, quality, and adherence to program directives.
8. Coordinate field and headquarter offices in the resolution of problems affecting program operations related to registration and listing for medical devices and/or radiological products.
9. Prepare compliance program evaluation reports for management review.
10. Design an appraisal system for compliance programs.
11. Conduct studies to measure the compliance of regulated industries with statutes and regulations to reduce consumer risk from medical devices.
12. Review data regarding recalls, complaints, registration and listing, export certificates and premarket approval clearance for medical devices and/or radiological products.
13. Advise staff on the practices of the medical device industry as identified by compliance programs.
14. Disseminate information regarding registration and listing policies for medical devices throughout an organization and external industry contacts.
15. Integrate registration and listing IT data and systems with external data and systems.
16. Provide guidance on registration and listing law, regulations and guidance.