Senior Consumer Safety Officer

Employer
USAJobs
Location
Silver Spring, Maryland
Posted
Apr 08, 2021
Closes
Apr 13, 2021
Hours
Full Time
Duties

Summary

The Center for Devices and Radiological Health (CDRH) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Learn more about this agency

Responsibilities

  • This position is located in the Food and Drug Administration, Center for Devices and Radiological Health, Office of Health Technologies IV (OHT4) in Silver Spring, Maryland.
  • As a Senior Consumer Safety Officer in the Office of Health Technology IV (OHT4), Immediate Office (IO), you will:
  • Apply a wide range of qualitative and quantitative methods to analyze and improve effectiveness in performing the consumer safety activities while assessing strengths and weaknesses;
  • Provide support in the selection and application of appropriate problem-solving methods and techniques;
  • Be recognized as an authority in consumer safety techniques relating to inspections and investigations which is highly complex and may involve scientifically difficult and politically sensitive issues;
  • Serves as an expert to the office in the field of general surgery and infection control devices compliance;
  • Train staff and personally explains critical and significant regulatory and compliance concepts, establishes methodologies, procedures, guidelines, and policies.
  • Conduct briefings, presentations, and meetings concerning alternative approaches for Center and Agency Officials, medical device industry representatives, health professional organizations, groups, and academia


Travel Required

25% or less - You may be expected to travel for this position.

Supervisory status
No

Promotion Potential
14

Requirements

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 applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.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.


Qualifications

The position of Senior Consumer Safety Officer falls within the 0696 occupational series. To qualify for this position at grade GS-14, you must meet Time-in-Grade requirements by 11:59 pm EST on 04/12/2021.

To Qualify for the Senior Consumer Safety Officer, GS-14 you MUST meet the basic requirement and specialized experience below:

Basic 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.

OR

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.

AND

Specialized experience:


For the GS-14 level, you must possess one year of experience, equivalent to at least the GS-13 level in the Federal service, this experience includes: Resolving complex scientific and/or regulatory issues relating to medical devices or radiological products; negotiating with medical device industry for acceptance of recommendations; and providing advice and guidance on regulatory matters involving the application or review process of medical devices or radiological products

Time-in-Grade: Any individual who is currently holding, or has held within the previous 52 weeks, a General Schedule position under non-temporary appointment in the competitive or excepted service, must meet time-in-grade requirements (must have served 52 weeks at the next lower grade or equivalent in the Federal service). Time-in-grade requirements must be met by the closing date of this announcement.

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 SF-50 or SF-52 documenting an official detail or other official assignment. The documentation 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 resume that is not within the official series and grade level of your official position, you must provide a copy of the appropriate documentation 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.

NOTE: It is your responsibility to ensure your responses and appropriate documentation is submitted prior to the closing date. To verify your application is complete, log into your USAJOBS account, https://my.usajobs.gov/Account/Login , select the Application Status link and then select the More Information link for this position. The Details page will display the status of your application, the documentation received and processed, and any correspondence the agency has sent related to this application. Your uploaded documents may take several hours to clear the virus scan process.

IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE WILL NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. Qualifications are based on breadth/level of experience. In addition to describing duties performed, applicants must provide the exact dates of each period of employment (from MM/YY to MM/YY) and the number of hours worked per week if part time. As qualification determinations cannot be made when resumes do not include the required information, failure to provide this information may result in disqualification. Applicants are encouraged to use the USAJOBS Resume Builder to develop their federal resume.

Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religious; spiritual; community, student, social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment. You will receive credit for all qualifying experience, including volunteer experience.

You must submit supporting documentation to verify your eligibility to apply for this vacancy.
For internal applicants an SF-50 will be required. If Educational requirements are listed, you must submit a Transcript, even if you occupy the series/grade in question.
See the Required Documents section for full details...

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 more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation .

SUBMITTING YOUR TRANSCRIPTS:
Positions which are scientific or technical in nature often have very specific educational requirements. A transcript is required to verify educational achievement. Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.
Electronic Transcript Caution : If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.
See the Application Manager Documentation for tips on submitting your paper-based documents.

Additional information

ADDITIONAL CONDITIONS OF EMPLOYMENT:

We may make additional selections for similar positions across the entire Department of Health and Human Services (HHS) within the local commuting area(s) identified in this vacancy announcement. By applying, you agree to have your application shared with any interested selecting official(s) at HHS. There is no option to opt-out as your information will not be shared with other hiring agencies outside of HHS.
  • Pre-employment physical required: NO
  • Drug testing required: NO
  • License required: NO
  • Mobility agreement required: NO
  • Immunization required: NO
  • Bargaining Unit Position: NO
  • If you are serving, or have served in the last 5 years (from 04/12/2021) 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. Political Appointees FAQ - OPM
  • 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 (04/12/2021); 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.

Additional selections may be made for similar positions across the Department of Health and Human Services (HHS) within the local commuting area(s) of the location identified in this announcement. By applying, you agree to have your application shared with interested selecting official(s) at HHS. Clearance of CTAP/ICTAP will be applied for similar positions across HHS.

Once the job opportunity announcement closes (at 11:59 pm Eastern Time on 04/12/2021), a review of your resume and supporting documentation will be conducted, the information will be compared against your responses to the assessment questionnaire to determine your eligibility for this internal position. Eligible internal candidates will be referred to the hiring official for consideration.

If you are referred to the hiring manager for consideration, you may be further evaluated based on an interview; review of requested work samples, writing samples, most recent performance evaluation(s), or professional references; or results of an oral presentation or work-related test. Failure to comply with any of the additional assessment requirements will result in removal from further consideration. These assessment methods/tools may also be listed under Key Requirements.

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 three categories: Best Qualified, Well-Qualified or Qualified.

Career Transition Assistance Program (CTAP): Well-Qualified is defined as an applicant who meets the qualification standards and eligibility requirements for the position, including minimum educational and experience requirements; any medical qualifications and suitability; is able to perform the essential duties of the position, with or without reasonable accommodation; meets any applicable selective placement factors) for the position (such as the ability to speak a specific language or any other factor required immediately upon hire); and is able to satisfactorily perform the duties of the position upon entry. To be well-qualified and exercise selection priority for this vacancy, surplus or displaced Federal employees must be rated at 85.0 or above on the rating criteria for this position. Learn more on the USAJOBS Career Transition Assistance Site .

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
  • Technical Competence
  • Compliance
  • Oral Communication
  • To preview the application questionnaire, click the link below.
    https://apply.usastaffing.gov/ViewQuestionnaire/11071564


    Background checks and security clearance

    Security clearance
    Other

    Drug test required
    No

    Position sensitivity and risk
    Noncritical-Sensitive (NCS)/Moderate Risk

    Trust determination process
    Suitability/Fitness

    Required Documents

    REQUIRED DOCUMENTS:
    • Resume
    • SF-50/ Notification of Personnel Action
    • Transcript

    Resume Requirements:
    • Resume Writing Tutorial
    • Resume Writing FAQ
    ACCEPTED DOCUMENTS:
    • Cover Letter
    • DD-214/ Statement of Service
    • Disability Letter (Schedule A)
    • Disability Letter (VA)
    • License
    • Other supporting documentation not listed above
    • PCS Orders
    • Performance Appraisal
    • Professional Certification
    • Resume
    • Separation Notice (RIF)
    • SF-15
    • SF-50/ Notification of Personnel Action
    • Transcript

    *Accepted documents may be required for some applicants depending on which eligibility options you're applying for, see the list below for details for each eligibility. If you need help submitting documentation, please see Applicant Help Site - Documents . If you are still unsure what documents might be required of you, please contact the FDA Applicant Help Desk before the announcement closes. For transcript submission requirements, see the Education section.

    Current and Former Federal Employees:
    To properly verify eligibility and time-in-grade, you must submit the following:
      SF-50 from your most recent Promotion, Within Rate/Grade Increase (WRI/WGI), Appointment, or Separation showing you are/were in the competitive service and the highest grade or promotion potential held. SF-50 submitted cannot be an annual pay adjustment or award. Your SF-50 must show the following information:
  • Full position title;
  • Appointment type;
  • Pay Plan, Series, Grade & Step;
  • Tenure code; and
  • Service Computation Date (SCD).
  • Learn more on the USAJOBS SF-50 Help Page . Schedule A:
    Individuals with intellectual disabilities, severe physical disabilities, or psychiatric disabilities, may apply for appointment through the Schedule A hiring authority. Certified verification of a disability from a licensed medical professional; a licensed vocational rehabilitation specialist; or any Federal, state, or District of Columbia agency or U.S. territory that issues or provides disability benefits will be required.
    Learn more on the USAJOBS Individuals with Disabilities Site .

    Displaced HHS employees:
    If you are a former Department of Health and Human Services employee who was displaced due to a Reduction-in-Force (RIF) or surplused by some other means, please submit a copy of the separation letter or RIF notice from your agency. To be selected under CTAP, you must still be found well-qualified for this position. See the How You Will Be Evaluated section for the agency's definition of well-qualified. Learn more on the USAJOBS Career Transition Assistance Site .

    VETERANS :
    • Active Duty Members (Veterans Opportunity to Work, VOW to Hire Heroes Act of 2011): submit written documentation from the armed forces that certifies the service member is expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the certification is submitted with your application package.
    • Parents of Deceased or Disabled Veterans (Gold Star Fathers Act of 2015): submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
    • Widow or Widower: submit a copy of the deceased or disabled veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference. Please follow the instructions in the SF-15 on required documentation to be submitted.
    • Spouse of a Living Veteran: submit a copy of the veterans' DD Form 214, Certificate of Release or Discharge from the armed forces that has the dates of service and discharge status AND the SF-15, Application for 10-point Veterans' Preference, and Documentation of Veteran's Inability to Work Because of a Service-Connected Disability. Please follow the instructions in the SF-15 on required documentation to be submitted.


    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 schools accredited by accrediting institutions recognized by the U.S. Department of Education .

    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.

    Similar jobs