Enter your Social Security Number in the space indicated. Your Social Security Number is requested under the authority of Executive Order 9397 to uniquely identify your records from those of other applicants who may have the same name. As allowed by law or Presidential directive, your Social Security Number is used to seek information about you from employers, schools, banks and others who may know you. Providing your Social Security Number is voluntary, however we can not process your application without it.
Are you a current Food and Drug Administration (FDA) employees with competitive status only? Competitive status refers to employees who are serving on a career or career conditional appointment.
Are you a PHS Commissioned Officer (This includes active duty officers, inactive reserve officers, and applicants who have been approved for commissioning in the USPHS Commissioned Corps)?
Are you eligible for noncompetitive appointment?
This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, persons with disabilities and PHS Commissioned Corps Officers. This also includes applicants who meet the qualifications for this position and who have previously held, or currently hold, a Federal position at the grade of this position.
Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.
If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?
Select/enter at least one occupational specialty. The specialty code for this position is:
Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:
Your response to the statement below will determine if you meet the area of consideration.
1. I am a current employee of the Food and Drug Administration, Office of Regulatory Affairs.A. Yes
Please answer yes or no to statement one. Your response will determine if you are qualified for the GS-13 Consumer Safety Officer (Medical Device/Radiological - MQSA) position.
2. I have at least one year of specialized experience that has equipped me with the particular knowledge, skills and abilities to successfully perform the duties of the position. This experience is related to the work of the position and equivalent to at least GS-12 level in the Federal Service as described in the vacancy announcement.A. Yes
3. From the descriptions below, select the one which best describes your education and/or experience and meets the basic qualification requirements for Consumer Safety Officer, GS-0696.A. I have a degree that included at least 30 semester hours in one or acombination of the following: biological sciences, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours can include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
Please answer yes or no to statement two. Your response will determine if you meet the time-in-grade requirement for this position.
4. I have 52 weeks at the GS-12 grade level or above in the Federal Service within 30 days of the announcement closing date.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. Note: Submission of this electronic questionnaire is certification that all responses are true to the best of your knowledge. Materially false, fictitious, or fraudulent statements or representations are subject to disciplinary action.A- I have not had education, training or experience in performing this task.
5. Conduct technical, complex, and multi-faceted inspections and in-depth investigations of medical devices.
6. Review reports of inspections and investigations for violations and determine the sufficiency of the evidence.
7. Serve as an expert witness in area of expertise in court cases dealing with regulated products.
8. Evaluate and make recommendations on necessary regulatory actions as required.
9. Conduct complex, technical investigations and inspections of medical devices.
10. Consult with appropriate personnel to identify the regulatory aspects that have bearing and influence on the decision as to whether violations encountered do or do not render a product a threat.
11. Conduct reviews of previously approved products within a programmatic area to determine if they meet current scientific safety criteria providing a course of action to resolve any violations if needed.
12. Developed operating policies and procedures to establish and provide program strategies.
13. Review and evaluate a variety of investigative methods within a programmatic area for use in conducting inspections and investigations.
14. Plans,conducts and directs complex inspections and investigations in the area of medical devices.
15. Provide advise on new regulated technology on medical device products, programs, laws and regulations involving medical device products.
16. Communicate directly with various FDA Regional offices, headquarters, state regulatory agencies, and CDRH in the course of performing medical device inspections and following up on compliance issues.
17. Participate in Field workshops and in industry seminars as the most knowledgeable field official in matters relating to medical devices.
18. Prepare and maintain reports documenting specific details of a complex, sensitive and critical nature pertaining to legal violations and threats to the public health.
19. Participate in the preparation of guidelines and other official documents.
20. Provide written adequate information involving investigations, inspections, lab test results, and breakdowns of imminent or potential hazards to consumer safety.