This Position Is No Longer Available
  1. Overview
  2. Duties
  3. Qualifications & Evaluations
  4. Benefits & Other Info
  5. How to Apply

Job Title:Lead Consumer Safety Officer

Department:Department Of Health And Human Services

Agency:Food and Drug Administration

Job Announcement Number:HHS-FDA-01-MP-13-941619

This position is closed and no longer accepting online applications through USAJOBS.

The contents of the announcement can still be viewed.

SALARY RANGE:

$105,211.00 to $136,771.00 / Per Year

OPEN PERIOD:

Wednesday, August 14, 2013 to Wednesday, August 28, 2013

SERIES & GRADE:

GS-0696-14

POSITION INFORMATION:

Full Time - Permanent

PROMOTION POTENTIAL:

14

DUTY LOCATIONS:

1 vacancy in the following location:
Silver Spring, MD United StatesView Map

WHO MAY APPLY:

Department of Health and Human Services Employees Only

JOB SUMMARY:

Become a part of the Department that touches the lives of every American!  At the Department of Health and Human Services (HHS) you can give back to your community, state, and country by making a difference in the lives of Americans everywhere.  It is the principal agency for protecting the health of citizens.  Join HHS and help to make our world healthier, safer, and better for all Americans.

Who May Apply:  This vacancy is open to current  Department of Health and Human Services  employees with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.

  

YOU MUST SUBMIT YOUR SF-50 .  If you have never served  in the GS-696, Consumer Safety Officer Series, you must also submit a transcript.

 

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. 

This position is located in the Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring. 

 

Salary range listed includes locality pay.

Additional Selections may be made. 

KEY REQUIREMENTS

  • U.S. Citizenship is required.
  • Travel Required: Occasional
  • Please carefully read and follow the instructions for HOW TO APPLY.
  • Must submit an SF-50
  • Transcripts are required if never served in the GS-696 series

DUTIES:

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Duties:

 

The incumbent will serve as a Lead  Consumer safety officer within the Division on an assigned team. 

 

The incumbent serves as the technical scientific authority involving programmatic operations involving enforcement of the Medical Device Amendments of 1976 including the Safe Medical Device Act of 1990 and 1992, and Radiation Control for Health and Safety Act of 1968.

 

Keeps fully abreast of crucial and precedent setting cases under review within the team and division in the medical device product industry as well as related cases in the Office.

 

Identifies and assesses emerging, standing, complex issues impacting the Office’s operational procedures and policies.

 

Ensure that the organization’s strategic plan, mission, vision and values are communicated to the team and integrated into the team’s strategies, goals, objectives, work plans and work products and services;

Lead the team in identifying, distributing and  balancing workload and tasks among employees in accordance with the established work flow, skill level and/or occupational specialization; making adjustments to accomplish the workload in accordance with established priorites io ensure timely accomplishment of assigned  team taska; and ensuring that each employee has an integral role in deveoping the final  team product.

Conducts briefings and presentations to the team, Deputy and Division Director for which the senior Consumer Safety Officer is responsible.  Frequently facilitates resolutions of difficult medical device compliance issues.

 

Participates in meetings on issues related to the programs, meets with representatives of regulated compliance firms and professional groups in the area.  Maintains continual relationships with other organizations within the Center and the Agency and the medical device industry.

 

Prepares written analyses and evaluations.  May serve as an expert witness in trials, and Congressional or court hearings.

 

Serves as a crucial developmental resource for lower level scientific employees and may provide training, assistance, and guidance to individuals in the area of compliance involving regulated medical devices.

 

 

 

 

 


QUALIFICATIONS REQUIRED:

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To qualify for the GS 14 grade level, applicants must have at least one year of specialized experience equivalent to the GS 13 or above in the Federal service.  Specialized experience is experience that has equipped the applicant with the knowledge, skills and abilities to perform successfully the duties of the position and that is typically in or related to the work of the position.  Examples of specialized experience may include experience in the field of medical devices and compliance; administrative and legal enforcement actions; medical device policy and program development, etc.


Education:

Individual Occupational Requirements

Basic Requirements:

     Degree: that included at least 30 semester hours in one or a combination 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 OR a combination of education and experience -- courses consisting of at least 30 semester hours in the fields of study described in A above, plus appropriate experience or additional education.

 Foreign Education:  If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.  For further information, visit: http://www.ed.gov.

 

Conditions of Employment:

 

1. Additional Security and Background Requirements:  May be referred depending on the position being filled.  If not previously completed, a background security investigation will be required for all appointees.  Appointment will be subject to the applicant's successful completion of a background security investigation and favorable adjudication.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  In addition, if hired, a background security reinvestigation or supplemental investigation may be required at a later time.  Applicants are also advised that all information concerning qualifications is subject to investigation.  False representation may be grounds for non-consideration, non-selection and/or appropriate disciplinary action.

 

2. All qualification requirements must be met by the closing date of the announcement.

 

3. Financial disclosure statement may be required.

 

4. Travel, transportation, and relocation expenses will be paid: No

 

5. Bargaining Unit Position: Yes

 

6. Drug Screening Required: No

 

7. Recruitment Bonus may be authorized: No

 

8. Research position: No

 

9. Supervisory position: No

 

10. Time in grade (TIG) must be by the closing date of the announcement.

HOW YOU WILL BE EVALUATED:

Once the application process is complete, a review of the resume and supporting documentation will be made and compared against your responses to the assessment questionnaire to determine if you are qualified for this job.  If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your qualifications and/or experience, you may lose consideration for this position.  Please follow all instructions carefully.  Errors or omissions may affect your eligibility.

 

Your qualifications will be evaluated and rated on the following competencies (knowledge, skills, abilities and other characteristics):

 

1.  Knowledge of and the ability to apply pertinent laws, regulations, policies, precedents, program goals and objectives in the broad field of medical devices.

2.  Ability to plan, organize, lead, and implement programs and initiatives in the area of medical devices.

3.  Ability to communicate in writing.

4.  Ability to communicate orally. 

 


BENEFITS:

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The Federal Government offers a comprehensive benefits package.  Explore the major benefits offered to most Federal employees at http://www.usajobs.gov/ResourceCenter/Index/Interactive/Benefits#icc.



OTHER INFORMATION:

Males born after December 31, 1959 must be registered or exempt from Selective Service (see http://www.sss.gov).

 

For information on "People with Disabilities" please visit http://opm.gov/disability/PeopleWithDisabilities.asp.

 

Career Transition Assistance Program (CTAP):  For information on how to apply as a CTAP eligible see http://opm.gov/rif/employee_guides/career_transition.asp#ctap.  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.



HOW TO APPLY:

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To begin the process, click the Apply Online button to create an account or log in to your existing USAJOBS account. Follow the prompts to complete the assessment questionnaire.  Please ensure you click the Submit My Answers button at the end of the process.

 

Note:  To return to a previously Saved or Incomplete application you may use the following link:  https://applicationmanager.gov.

 

To fax supporting documents you are unable to upload, complete this cover page http://staffing.opm.gov/pdf/usascover.pdf using the following Vacancy ID 941619.  Fax your documents to 1-478-757-3144.

 

If you cannot apply online:

  1. Click the following link to view and print the assessment questionnaire View Occupational Questionnaire, and
  2. Print this 1203FX form to provide your response to the assessment questionnaire http://www.opm.gov/forms/pdf_fill/OPM1203fx.pdf and
  3. Fax the completed 1203FX form along with any supporting documents to 1-478-757-3144.  Your 1203FX will serve as a cover page for your fax transmission.
  4. This agency provides reasonable accommodation to applicants with disabilities.  If you need a reasonable accommodation for any part of the application and hiring process, please contact the Bethesda Center HelpDesk Telephone (888)-478-4340; TTY/TDD: (866)-539-4484; or by email quickquestions@fda.hhs.gov.  The decision on granting reasonable accommodation will be made on a case-by-case basis.


REQUIRED DOCUMENTS:

To apply for this position, you must provide a complete Application Package which includes:

  1. Your Résumé - You are encouraged to use the USAJobs online resume builder to ensure that all required information is in your resume.  If you use your own résumé, curriculum vitae, or any other written form you choose then you must describe your job-related qualifications that include beginning and ending dates for paid and non-paid work experience, hours worked per week, month and year of employment for each job title listed.

  2. A complete Assessment Questionnaire

  3. Other supporting documents:

  4.      - SF-50 (if you are a federal employee or have reinstatement rights as a federal employee)

         - PHS Commissioned Corps Officer must submit a copy of latest personnel order

         - College Transcripts (if the position has a positive education requirement)

Note:  You may submit an unofficial transcript or a list of college courses completed indicating course titles, credit hours, and grades received.  An official transcript from an accredited educational institution is required if you are selected for the position.

 

For Résumé and Application Tips visit: http://www.usajobs.gov/ResourceCenter/Index/Interactive/ResumeAndApplicationTips#icc.

 

The complete Application Package must be submitted by 11:59 PM (EST) on Wednesday, August 28, 2013.

AGENCY CONTACT INFO:

FDA Helpdesk
Phone: (888)478-4340
Fax: (478)757-3144
Email: QUICKQUESTIONS@PSC.GOV
Agency Information:
HHS FDA Center
10903 New Hampshire Avenue
Silver Spring, MD
20993 Fax: (478)757-3144

WHAT TO EXPECT NEXT:

Once the online questionnaire is received you will receive an acknowledgement email that your submission was successful.  The most highly qualified candidates will be referred to the hiring manager for further consideration and possible interview.  We expect to make a selection within 45 days of the closing date of this announcement.


You will receive notice via email or by mail, if no email address was provided by you during the application process, once this process is completed (generally 4-6 weeks).


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Job Announcement Number:

HHS-FDA-01-MP-13-941619

Control Number:

349375900