This position is located in the Food and Drug Administration, Center for Devices and Radiological Health (CDRH), Office of Compliance (OC), Division of International Compliance Operations (DICO), which focuses on foreign device manufacturer and importer assessment; compliance audit programs, medical device compliance policy, and guidance development; export operations and policy; and stakeholder communication and outreach.
Develops program policy and procedures for the Office, Center, and Agency through leadership and participation in working groups and guides implementation for the Office/Center.
Obtains resources and identifies strategic objectives for the organization.
Supervisor provides occupational specific technical and administrative direction 25 percent or more of the time to three or more subordinate employees performing the work and functions of the organization.
Develops, reviews, and revises new and amended regulations including good manufacturing practices (GMPs) and standards for electronic products.
Conducts briefings, presentations, and meetings concerning these alternative approaches for Center and Agency Officials, medical device and radiological health industry representatives, health professional organizations, groups, and academia.
Job family (Series)
Conditions of Employment
Citizenship Requirement: You must be a U.S. Citizen to be considered for this advertisement unless explicitly stated otherwise.
FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
Selective Service Registration: All males born on, or after, 12/31/1959, must be registered with the Selective Service OR have an approved exemption. VIsit SSS.gov for more info.
Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
Time-in-Grade Requirement: If you are applying as a current Federal employee, you must meet the time-in-grade requirements described in the Qualifications section, generally, 52-weeks of comparable experience at the next lowest grade.
Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
You must meet ALL requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities.
In order to qualify for Supervisory Consumer Safety Officer, 0696, at
GS - 15, you must meet requirements by 08/23/2018.
Applicants must meet one of the following requirements.
A. A bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming.
B. Combination of education and experience--courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.
One year of specialized experience equivalent to at least the GS-14 level in the Federal service obtained in either the private or public sector. Experience should include managing people and projects; and developing policies and procedures related to the regulation of medical products.
In accordance with Office of Personnel Management policy, federal employees are assumed to have gained experience by performing duties and responsibilities appropriate for their official series and grade level as described in their position description. Experience that would not normally be part of the employee's position is creditable, however, when documented by satisfactory evidence, such as a signed memorandum from the employee's supervisor or an or SF-52 documenting an official detail or other official assignment. The must indicate whether the duties were performed full time or, if part time, the percentage of times the other duties were performed. It is expected that this documentation is included in the employee's official personnel record. In order to receive credit for experience in your that is not within the official series and grade level of your official position, you must provide a copy of the appropriate of such experience as indicated above.
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
You must submit to verify your to apply for this vacancy. For internal applicants an will be required.
See the Required Documents section for full details.
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 more information about this requirement, please visit the .
ADDITIONAL CONDITIONS OF EMPLOYMENT:
Pre-employment physical required:
Drug testing required:
Mobility agreement required:
Bargaining Unit Position: NO
If you are serving, or have served in the last 5 years (from 08/23/2018) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.
You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire.
Financial disclosure statement, OGE-450, required:
This position will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers.
All requirements must be met by the closing date of this announcement (08/23/2018); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the hiring process.
Additional selections may be made within the same geographical area FDA-wide.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 08/23/2018), of your and will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.
Please follow all instructions carefully. Errors or omissions may affect your eligibility.
Basis of Rating:
Merit Promotion Procedures for the Food and Drug Administration (FDA) will be used to rate and rank candidates. The category assignment is a measure of the degree in which your background matches the competencies required for this position. Qualified candidates will be ranked into one of two categories:
Best Qualified or Qualified.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics). You do not have to respond to the KSA's separately, but your resume should contain sufficient information to demonstrate possession of the Competencies/KSA's.
Planning and Evaluating
Supervise and Manage
To preview the application questionnaire, click the link below.
Background checks and security clearance
Drug test required
The following documents are REQUIRED
for this vacancy:
PCS Orders/SF 50
Required indicates that the above documents are necessary to determine your eligibility and/or qualification for this vacancy. These documents are collected from ALL applicants and failing to provide any of these documents may result in your application being deemed incomplete or ineligible. Pay close attention to the list above to ensure you are providing all of the documentation we need to consider your application.
If you need instructions or assistance with submitting documentation, please see the page for more information.
The Federal Government has very specific requirements for the information that you must include in your resume. A resume for a Federal job will be much longer and more complete than the type of resume you may be familiar with from the private sector, especially if you are accustomed to using the CV (curriculum vitae) format. If you have not written a Federal resume before, you may want to watch this
on the , or read through a helpful
on the to learn what details you should, and should not, include in your resume. At a minimum, you should include: start and end dates for each position (including month and year), number of hours per week worked, level of experience and duties performed, employer name and address, supervisor name and contact, and salary (or grade and step), for each position listed in your work history.
The following documents are ACCEPTED
for this vacancy:
PCS Orders/SF 50
Accepted means that you will have the opportunity to submit these documents if they are applicable to you. Such documents include Veteran Preference or other special eligibility documentation, transcripts, or other optional documentation that helps us determine your eligibility. The above list of documents may not apply to all applicants.
FDA EMPLOYEE DOCUMENTATION REQUIREMENTS FOR SF-50:
Current and former Federal employees:
You will need to submit a copy of your most recent SF-50 (Standard Form 50 - Notice of Personnel Action). To properly verify status eligibility, your SF-50 must show the following. If you do not submit an appropriate SF-50, we cannot verify your status eligibility! Full position title;
Pay plan, series, grade, and step;
Tenure code; and
Service Computation Date (SCD).
If your current position does not indicate you have competitive service status or does not reflect the pay plan and grade of the highest position you have held in the competitive service, in addition to your current SF-50, you must provide your previous SF-50s that provide the proof of competitive status and highest grade held on a permanent basis.
Displaced Federal employees who qualify for CTAP:
If you are a former FDA employee, involuntarily separated (displaced) due to a Reduction-in-Force (RIF), please submit a copy of the separation letter or RIF notice you received from the agency. To be selected under CTAP, you must still be found well-qualified for this position. Please see USAJOBS site for more information.
If you are relying on your education to meet qualification requirements:
Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from.
Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding. .
Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time, or intermittent. Contact the hiring agency for more information on the specific benefits offered.
How to Apply
To apply for positions with the Food & Drug Administration, you must have a account and be signed in to that account before you click the Apply Online button.
See the USAJOBS Help Article for more on this process.
Additionally, you must provide a resume any required supporting documentation listed on the announcement, and you must complete all assessment questionnaires BEFORE 11:59 pm Eastern Time on the closing date of this announcement,08/23/2018. We recommend that you start the application process early enough that you can complete and submit your application before this deadline.
Please note that you cannot submit documentation or make changes to your application after the closing date.
If you would like to learn how to use USAJOBS including: accessing and managing your account, adding saved documents, building a resume, or starting an application; we recommend you visit the USAJOBS How To site, and read up on any topic that you need help with. This site is located at: . Additionally, if you need technical assistance with USAJOBS (such as account issues) please visit the main USAJOBS Help site at: . FDA's Applicant Help Desk cannot assist you with USAJOBS-related issues.
The Food & Drug Administration uses a system called Application Manager (USA Staffing) to post jobs and accept applications. If you are not familiar with Application Manager or you encounter any difficulty with the site, we recommend that you visit the Applicant HELP Site at: . This help site contains step-by-step instructions for completing the application process, submitting documentation, and completing questionnaires, and should be very helpful to you!
You are encouraged to apply online. Applying online will allow you to review and track the status of your application. The FDA will provide to applicants with disabilities who are not able to apply online. If you need a reasonable accommodation for any part of the application process, please ****
, or e-mail .
The Applicant Help Desk is staffed between the hours of 7am and 6pm Eastern Time, Monday through Friday, except for government holidays.
If you contact the Applicant Help Desk, please provide the following Vacancy Identification Number (VIN) 10270527 so that we may assist you faster.
Agency contact information
FDA Applicant Help Desk
Center for Devices and Radiological Health
10903 New Hampshire Ave
Silver Spring,MD 20993
Once you submit your application 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 strive to make selections within 45 days of the closing date of this announcement.
You will application status updates via email and via USAJOBS as the process unfolds.
Fair & Transparent
The Federal hiring process is setup to be fair and transparent. Please read the following guidance.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Equal Employment Opportunity (EEO) for federal employees & job applicants
Reasonable Accommodation Policy
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when: An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Learn more about or
Legal and regulatory guidance
This job originated on . For the full announcement and to apply,visit .Only resumes submitted according to the instructions on the job announcement listed at will be considered.