Regulatory Policy Analyst


Vacancy ID: 764706   Announcement Number: HHS-FDA-13-MP-764706   USAJOBS Control Number: 328658700

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 764706
1. Title of Job

Regulatory Counsel
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 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)?


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

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

15. Dates of Active Duty - Military Service

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

16. Availability Date

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

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 code. The specialty code(s) for this position are 001 and 002. Please note that you must select at least one specialty code but may select both codes if desired. Each code is defined below:

 

001 - Competitive merit promotion. This includes current Federal employees who serve under a competitive career-career conditional appointment in the competitive service, reinstatement eligibles (former Federal employees who served under a career appointment in the competitive service), and VEOA eligibles (veterans with preference and veterans who have been honorably discharged and substantially completed at least 3 years of continuous active duty service).

 

002 - Noncompetitive merit promotion. This includes applicants who are eligible for special or noncompetitive appointment authorities such as 30% or more compensable disabled veterans, and persons with disabilities. 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.

 


001 Competitive
002 Non-Competitive

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

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

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: preparing Unified Agenda and Regulatory Plan for publication in the Federal Register; assisting in the development, drafting, and critical review of regulations, legislative proposals and other documents embodying policy and program proposals and decisions, with reports justifying them and explaining their impact; Consulting and advising Senior management, other officials and other segments of the agency on the application of federal statutes and development of implementing regulations and administrative policies.

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 Food and Drug Administration 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 Center-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 Center and Agency needs in terms of national goals and developing the direction organizations' regulatory programs and policies related to emerging health technologies.

10. Evaluate Center'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 Center's mission and strategic priorities.

12. Interpret laws/guidelines pertaining to medical products.

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

14. Working knowledge of software development practices related to medical devices.