Lead Consumer Safety Officer

Employer
USAJobs
Location
Washington D.C.
Posted
Jul 05, 2017
Closes
Jul 20, 2017
Function
Administrative
Hours
Full Time
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.

This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of in Vitro Diagnostics and Radiological Health, Division of Microbiology in Silver Spring, Maryland.

This vacancy is also being announced concurrently with vacancy announcement FDA-CDRH-17-MP-1947543MB under merit promotion procedures.  Please review that announcement to see if you are eligible for consideration under merit promotion procedures. 

NOTE:  Applicants must apply separately for each announcement in order to be considered.

Who May Apply: Open to all United States Citizens.

Additional selections may be made within the same geographical area FDA-wide.


TRAVEL REQUIRED:
  • Occasional Travel
  • 5% travel may be required

RELOCATION AUTHORIZED:
  • No

KEY REQUIREMENTS:
  • U.S. Citizenship is required.
  • Only experience gained by closing date announcement will be considered.
  • One year probationary period may be required.
  • Positive Education Requirement
  • BASIC QUALIFICATION 

    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-

    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.

    ADDITIONAL MINIMUM QUALIFICATIONS

    In addition to the Basic Qualification Requirement, you must meet the following in order to qualify for a Lead Consumer Safety Officer, GS-0696-14 position:

    You must have one (1) year of specialized experience that is equivalent to at least the GS-13 grade level in the Federal service which includes utilizing provisions of the Food, Drug, and Cosmetics Act (FD&C) related to medical devices and radiological products in order to ensure compliance while providing support in the development of in vitro diagnostic medical devices or radiation-emitting products;overseeing and evaluating team project activities, and  delivering presentations to management staff or external groups on technical or scientific subject matter.

    If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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.  For further information, click on foreign education.

    Conditions of Employment: 

    1. Security and Background Requirements:  Appointment will be subject to the applicant's successful completion of a background security investigation.  Failure to successfully meet these requirements may be grounds for appropriate personnel action.  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 or appropriate disciplinary action. 
    2. E-Verify:  If you are selected for this position, the documentation that you present for purposes of completing the Department of Homeland Security (DHS) Form I-9 will be verified through the DHS "E-Verify" System.  Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system.  The U.S. Department of Health and Human Services is an E-Verify Participant. 
    3. Direct Deposit:  All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.  
    4. Pre-employment physical required: No
    5. Drug testing required: No
    6. License required: No
    7. Mobility agreement required: No
    8. Immunization required: No
    9. Incentives may be authorized; however, this is contingent upon funds availability. If authorized, certain incentives will require you to sign a service agreement to remain in the Federal government for a period of up to 3 years. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
    10. Bargaining Unit Position: No
    11. All qualification requirements must be met by the closing of the announcement.
    Please be advised this position will be subject to FDA's strict prohibited financial interest regulation and therefore, may require the incumbent of this position to divest of certain financial interests.  Applicants are strongly advised to seek additional information on this requirement from the FDA hiring official before accepting this position.

    Q - Nonsensitive


    DUTIES:

      If selected for this position, you will:
    • Serve as an expert scientist to the office and division in the field of medical devices and radiological health compliance, and is responsible for evaluating the programs and activities of the team;
    • Maintain close personal contact with the "regulated medical device industry" in the area of expertise in order to inculcate the most advanced theories and practices in the compliance field into the team, division, and office programs;
    • Serve as a technical scientific authority on programmatic operation 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;
    • Identify and assess emerging, standing, complex, or precedent-setting issues affecting the Office of in Vitro Diagnostics and Radiological Health operational procedures and policies;
    • Prepare written analyses and evaluations for and participate in face-to-face discussions with Agency professionals and may serve as an expert witness in trials, and Congressional or court hearings where testimony may be challenged by medical device researchers, industry and/or Congress.