Regulatory Policy Analyst - OCD


Vacancy ID: 841206   Announcement Number: HHS-FDA-MP-13-841206   USAJOBS Control Number: 338705300

Social Security Number

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.


Vacancy Identification Number

Enter 841206
1. Title of Job

Regulatory Policy Analyst - OCD
2. Biographic Data

3. E-Mail Address

4. Work Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

5. Employment Availability

Are you an ICTAP Eligible?

For information on how to apply as an ICTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ictap.  To be well-qualified and exercise selection priority for this vacancy, displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position.


Are you eligible for Indian preference as defined by the Department of the Interior (DOI) and as evidenced by appropriate Bureau of Indian Affairs (BIA) authorized certification?


Are you eligible for preference based on being a Public Law 94-437 Indian Health Service Scholarship recipient? For more information, please click here.    


Are you eligible for the Federal Employment Program for Persons with Disabilities? (For information on Schedule A appointments, see the OPM website.)    


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.


6. Citizenship

Are you a citizen of the United States?
7. Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

8. Other Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

9. Languages

If you are applying by the OPM Form 1203-FX, leave this section blank.

10. Lowest Grade

Enter the lowest grade level that you will accept for this position. The lowest grade for this position is 13.


13

11. Miscellaneous Information

If you are a male at least 18 years of age, born after December 31, 1959, have you registered with the Selective Service System?


01 Yes
02 No
03 Not Applicable

12. Special Knowledge

If you are applying by the OPM Form 1203-FX, leave this section blank.

13. Test Location

If you are applying by the OPM Form 1203-FX, leave this section blank.

14. Veteran Preference Claim

15. Dates of Active Duty - Military Service

16. Availability Date

17. Service Computation Date

If you are applying by the OPM Form 1203-FX, leave this section blank.

18. Other Date Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

19. Job Preference

If you are applying by the OPM Form 1203-FX, leave this section blank.

20. Occupational Specialties

Select/enter at least one occupational specialty. The specialty code for this position is:


001 Regulatory Policy Analyst

21. Geographic Availability

Select/enter at least one geographic location in which you are interested and will accept employment. The location code for this position is:


241450031 Silver Spring, MD

22. Transition Assistance Plan

23. Job Related Experience

If you are applying by the OPM Form 1203-FX, leave this section blank.

24. Personal Background Information

If you are applying by the OPM Form 1203-FX, leave this section blank.

25. Occupational/Assessment Questions:

Thank you for your interest in the Regulatory Policy Analyst, GS-0301-13, position at our Agency. We will evaluate your resume and your responses to this Assessment Questionnaire to determine if you are among the best qualified for this position. Your responses are subject to verification. Please review your responses for accuracy before you submit this questionnaire.

1. For the GS-13, you must demonstrate in your resume at least one (1) year of qualifying experience equivalent to at least the GS-12 level in the Federal service. Examples of specialized experience include: advising the supervisor on regulatory and policy making activities that affect programs, projects and initiatives; researching and analyzing unstable or complex regulatory policy issues; drafting and critically reviewing documents; embodying policy and program proposals and decision; identifying and assessing emerging, standing, complex, or precedent setting issues impacting on procedures, policies, activities, and resources; and assisting in coordination with other federal agencies and external organizations to further the mission and strategic priorities.

A. 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 the GS-13 level in the Federal service as described in the vacancy announcement.
B. I do not possess the experience or education described above.

2. Are you a current Department of Health and Human Services employee?

A. Yes
B. No

For each task in the following group, choose the statement from the list below that best describes your experience and/or training.

A- I have not had education, training or experience in performing this task.
B- I have had education or training in performing the task, but have not yet performed it on the job.
C- I have performed this task on the job. My work on this task was monitored closely by a supervisor or senior employee to ensure compliance with proper procedures.
D- I have performed this task as a regular part of a job. I have performed it independently and normally without review by a supervisor or senior employee.
E- I am considered an expert in performing this task. I have supervised performance of this task or am normally the person who is consulted by other workers to assist them in doing this task because of my expertise.

3. Advise management on regulations and policies that impact organization-wide programs related to emerging health technologies such as mobile health.

4. Provide expert guidance on the Federal Food & Drug and Cosmetic Act, as it pertains to the regulation of emerging health technologies.

5. Develop policies and programs related to medical device software.

6. Prepare written correspondence, documents, briefings, or reports for peers and teams; supervisors and managers; high level officials; audiences and organizations outside and professional publications.

7. Extract and formulate information from multiple sources for highly complex and comprehensive reports.

8. Draft regulations, guidance materials, program proposals, and policy recommendations.

9. Assist in efforts related to identifying organizational needs in terms of national goals and developing the direction organizations' regulatory programs and policies related to emerging health technologies.

10. Evaluate an organization's overall efforts and activities to develop, establish, or recommend information for creating or finalizing polices related to emerging health technologies.

11. Assist with coordination of other federal agencies and external organizations to further the organization's mission and strategic priorities.

12. Interpret laws and guidelines pertaining to medical products.

13. Perform special assignments involving complex issues related to Agency's programs, strategies, and activities.

As previously explained, your responses in this Assessment Questionnaire are subject to evaluation and verification. Later steps in the selection process are specifically designed to verify your responses. Deliberate attempts to falsify information will be grounds for disqualifying you or for dismissing you from employment following acceptance. Please take this opportunity to review your responses to ensure their accuracy.
If you fail to answer this question, you will be disqualified from consideration for this position.

14. I certify that, to the best of my knowledge and belief, all of the information included in this questionnaire is true, correct, and provided in good faith. I understand that if I make an intentional false statement, or commit deception or fraud in this application and its supporting materials, or in any document or interview associated with the examination process, I may be fined or imprisoned (18 U.S.C. 1001); my eligibilities may be cancelled, I may be denied an appointment, or I may be removed and debarred from Federal service (5 C.F.R. part 731). I understand that any information I give may be investigated. I understand that responding "No" to this item will result in my not being considered for this position.

A. Yes, I certify that the information provided in this questionnaire is true, correct and provided in good faith, and I understand the information provided above.
B. No, I do not certify/understand the information provided above.