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1. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Biologist, GS-0401.A. Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
2. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Microbiologist, GS-0403.A. Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.
3. From the description below, select the one which best describes your education and/or experience and meets the Basic Qualification Requirements for Supervisory Toxicologist, GS-0415.A. Degree: toxicology; or an appropriate discipline of the biological, medical, or veterinary sciences that included at least 30 semester hours in chemistry, biochemistry, or physiology,
4. From the description below, select the one which best describes your specialized experience and meets the Additional Qualification Requirements for Biologist, GS-401-14; Microbiologist, GS-403-14 and Toxicologist, GS-415-14.A. I have one year of specialized experience, equivalent to at least the GS-13 level in the Federal Service, serving as a scientific or engineering reviewer, supervisor or senior advisor in the area of medical device evaluation as it relates to the review and evaluation of premarket notification submissions, premarket applications and/or investigational device exemptions for premarket approval prior to entry into the marketplace.
5. Are you a permanent Food and Drug Administration employee?A. Yes
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.
6. Manages a staff of scientists, engineers, CSOs and health care professionals in the administrative, regulatory and scientific review of pre-market notifications (510(k)s), IDEs, PMAs and reclassification petitions.
7. Provides technical leadership and judgment in the evaluation of complex issues involving devices which have a significant impact on the safety and effectiveness of various urology and lithotripsy medical devices or other medical device products.
8. Serves as a focal point, advisor and primary contact for medical device regulatory and scientific issues relative to various products/submissions.
9. Provides expert and authoritative advice, guidance, assistance, interpretations, consultations and recommendations to top level and senior Agency and Departmental officials, program directors, scientific and professional personnel and industry representatives.
10. Provides technical consultation of various medical device products.
11. Participates in technical work groups where the safety and effectiveness of urology and lithotripsy devices are discussed.
12. Plans and organizes activities of the Branch, such as review of reclassification petitions, premarket approval and/or research programs.
13. Serves as a technical expert and advisor in the area of preclinical and clinical testing of various medical device products as they relate to investigational device exemptions, premarket notifications and applications for premarket approval.
14. Coordinates the work of personnel which include Scientists, Engineers, Consumer Safety Officers, Health Care Professionals and support personnel in the administrative, regulatory and scientific review of pre-market notifications and petitions.
15. Provides guidance involving complex questions of opinion and policy.
16. Provides overall management and administrative direction to the clerical and professional staff.
17. Reviews and evaluates scientific activities in terms of achieving program goals and objectives and accomplishing assigned functional responsibilities.
18. Provides technical and clinical guidance to the staff on precedent setting and controversial issues involving complex questions of opinion and policy.
19. Represents the Division Director at various meetings, if necessary, with foreign manufacturers, health care professionals and government officials, and at international meetings.
20. Participates in inter-Agency task groups as an expert or senior reviewer and also participates in technical working groups in other Agencies or Centers.
21. Confers with industry officials and medical and/or scientific experts in the urology and lithotripsy device area or other medical device arena regarding the regulation of various device products.