This position is located at 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 (OIR) located in Silver Spring, Maryland.Learn more about this agency
This vacancy is also being announced with vacancy announcement FDA-CDRH-18-DE-10134062JL under competitive (open to All U.S. Citizens) procedures. Please review that announcement to see if you are eligible for consideration under competitive procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
Additional selections may be made within the same geographical area FDA wide.
- Acting as a senior reviewer of in vitro diagnostics, medical devices, and/or radiation emitting products in regards to safety and effectiveness.
- Analyzing data related to pre- and post-market notification submissions, radiation emitting products, and related supplements and amendments.
- Enforcing a wide variety of medical device or radiological health regulations to provide authoritative guidance to both internal and external groups.
- Planning and developing audit programs designed to assess conformance with medical or radiological health device standards and regulations.
- Collaborating with other scientists and regulated industry to improve medical device safety or standards for radiological health products.
Occasional travel - You may be expected to travel for this position.
Conditions of Employment
- U.S. Citizenship is required
- One-year probationary period may be required
- Must meet time-in-grade restrictions by closing date of announcement
- Registered or exempt from Selective Service (www.sss.gov)
- 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 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.
- All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- Pre-employment physical required: No
- Drug testing required: No
- License required: No
- Mobility agreement required: No
- Immunization required: No
- 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.
- Bargaining Unit Position: Yes
- Financial disclosure statement required: No
- All qualification requirements must be met by the closing date of this announcement.
QualificationsTime-in-Grade: One year at the GS-12 level is required to meet the time-in-grade requirements for the GS-13 level.Under competitive merit promotion procedures, any individual who is currently holding, or who has held within the previous 52 weeks, a General Schedule position under a non-temporary appointment in the competitive or excepted service, must meet "time-in-grade" requirements (have served 52 weeks at the next lower grade of the grade for which you are applying). Time-In-Grade requirements also apply to current employees applying for a Veterans Employment Opportunities Act of 1998 (VEOA) appointment. NOTE: You must provide a copy of your SF-50 (you may need to submit more than one), "Notice of Personnel Action" that indicates proof of status and time-in-grade eligibility. The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).
In order to qualify for the Interdisciplinary Scientist, GS-1310/1320-13 level, you must meet one of the following basic requirements (you must submit a copy of your transcripts) AND specialized experience below.
For the 1310 Physicist Basic Requirement, you must possess:
A. A bachelor's or higher degree in physics; or related degree that included at least 24 semester hours in physics. Courses must have included a fundamental course in general physics and, in addition, courses in any two of the following: electricity and magnetism, heat, light, mechanics, modern physics, and sound.
B. Combination of education and experience-- courses equivalent to a major in physics totaling at least 24 semester hours, plus appropriate experience or additional education. Courses must have included a fundamental course in general physics and, in addition, courses in any two of the following: electricity and magnetism, heat, light, mechanics, modern physics, and sound.
For the 1320 Chemist Basic Requirement, you must possess:
A. A bachelor's or higher degree in physical sciences, life sciences, or engineering that included 30 semester hours in chemistry, supplemented by course work in mathematics through differential and integral calculus, and at least 6 semester hours of physics.
B. Combination of education and experience--course work equivalent to a major as shown in A above, including at least 30 semester hours in chemistry, supplemented by mathematics through differential and integral calculus, and at least 6 semester hours of physics, plus appropriate experience or additional education.
You must have at least one full-time year (12-months) of specialized experience equivalent to at least the GS-12 grade level in the Federal service that included:
- Reviewing scientific data or information to identify risks or problems and assist in disposition recommendations of in vitro diagnostics, medical devices, or radiological health products.
- Using established scientific procedures or techniques to evaluate in vitro diagnostics, medical devices, or radiological health products.
- Making recommendations to supervisor concerning regulatory or scientific guidance related to in vitro diagnostics, medical devices, or radiological health products.
(This experience must be clearly demonstrated in your resume).
IN DESCRIBING YOUR EXPERIENCE, PLEASE BE CLEAR AND SPECIFIC. WE MAY NOT MAKE ASSUMPTIONS REGARDING YOUR EXPERIENCE. If your resume does not support your questionnaire answers, we will not allow credit for your response(s).
NOTE: 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; community; student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to gain employment. You will receive credit for all qualifying experience, including volunteer experience. If such experience is on a part-time basis, you must provide the average number of hours worked per week as well as the beginning and ending dates of the experience so it can be fully credited.
Documenting experience: 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.
This position requires specific coursework and/or a degree to meet the basic education requirement. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Your transcript(s) must clearly demonstrate the course(s) listed in the qualification requirement section. If the transcript(s) does not clearly demonstrate this you must submit a copy of the course description and/or other documentation demonstrating that the courses are equivalent.
Special Instructions for 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. Failure to provide such documentation with your application will result in lost consideration. For further information, visit: https://sites.ed.gov/international/recognition-of-foreign-qualifications/.
Political Appointment: If you are serving, or have served in the last 5 years (from the close of this announcement) 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 questionnaire and certify your responses.
Veterans Employment Opportunities Act (VEOA): To be eligible for a VEOA appointment, the veteran must 1) be a preference eligible; or 2) be a veteran separated after 3 or more years of continuous active service performed under honorable conditions (you must submit a DD214-member copy 4).
Career Transition Program: This program applies to Federal service employees whose positions have been deemed surplus or no longer needed, or employees who have been involuntarily separated from a Federal service position within the competitive service. To receive selection priority for this position, you must: 1) meet eligibility criteria for CTAP or ICTAP; 2) be rated well-qualified (score an 85 or higher) for the position; and 3) submit the appropriate documentation to support your CTAP or ICTAP eligibility. Well-Qualified includes those applicants whose knowledge, skills, and abilities clearly exceed the minimum qualification requirements for the position. For information on eligibility criteria and required documentation, go to: http://www.opm.gov/rif/employee_guides/career_transition.asp
Noncompetitive Appointment Authorities: The following links contain information on the eligibility requirements to be considered under a noncompetitive appointing authority:
Persons with Disabilities-Schedule A
Special Hiring Authorities for Veterans
Special Hiring Authority for Certain Military Spouses
Other Special Appointment Authorities
Selective Service: Males born after 12/31/59 must be registered or exempt from Selective Service (see http://www.sss.gov/).
Reasonable Accommodation: 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 Customer HelpDesk at (888) 478-4340; TTY/TDD: (800) 877-8339; or by email email@example.com. The decision on granting reasonable accommodation will be made on a case-by-case basis.
You are encouraged to apply online. If you are unable to apply online or need to fax a document you do not have in electronic form, view the following link for information regarding an Alternate Application.
How You Will Be Evaluated
You will be evaluated for this job based on how well you meet the qualifications above.
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.
For Competitive Merit Promotion and Veterans Employment Opportunities Act (VEOA) Applicants: The highest rated candidates will be referred to the hiring agency.
For Noncompetitive Appointment Eligibles: All qualified candidates will be referred to the hiring agency.
Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics).
- Compliance Inspection
- Interpersonal Skills
- Medical Devices and Products
- Oral Communication
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.
To preview the assessment questionnaire, click the following link: https://apply.usastaffing.gov/ViewQuestionnaire/10134063
Background checks and security clearance
- 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, you must provide a detailed description of your job-related qualifications that includes beginning and ending dates with the month and year and hours worked per week (if less than 40) for each paid and non-paid work experience job title listed. Full-time employment will be assumed unless otherwise stated on your resume. Part-time employment will be prorated in crediting experience. Not providing this information may result in the lowering of your assessment score or an ineligible rating. For resume writing guidance, please visit the USAJobs Resource Center or view their video tutorial.
- Responses to the Assessment Questionnaire (https://apply.usastaffing.gov/ViewQuestionnaire/10134063)
- Standard Form 50 (if you are a current or former Federal service employee). The SF-50 must include your position, title, series, grade, step, tenure, type of service (Competitive or Excepted) and career status (career or career-conditional).
- You may need to submit more than one SF-50 to demonstrate that you meet time-in-grade requirements. Recommended SF-50s include: promotions and step increases (within grade increases)
- If you have separated from Federal Government employment, you may obtain a copy of your SF-50 via: National Personnel Records Center, Annex, 1411 Boulder Boulevard, Valmeyer, IL 62295; FAX - 618-935-3014; Email CPR (mail to: CPR.CENTER@NARA.GOV); or visit the National Archives Website (http://www.archives.gov/st-louis/civilian-personnel/index.html).
- Cover letter
- College transcripts (if qualifying all or in part based on your education)
- Veterans' Preference documentation:
- Discharged Veterans: If you are claiming 5 point preference, you must submit a copy of your DD Form 214, Certificate of Release or Discharge from the armed forces that supports dates of service and discharge status; if claiming 10 point preference, an application for 10-Point Veterans Preference (SF-15) and an official document dated 1991 or later, from the Department of Veterans Affairs or from a branch of the Armed Forces, and/or any other associated documentation based on your preference.
- Active Duty Members: Under the VOW (Veterans Opportunity to Work) to Hire Heroes Act of 2011, if claiming 5 point preference, 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.
- PHS Commissioned Corps Personnel Orders or other supporting documentation.
- CTAP/ICTAP documentation
- A copy of your RIF separation notice, notice of proposed removal for failure to relocate, notice of disability annuity termination, or certification from the National Guard Bureau or Military Department that you are eligible for disability retirement;
- A copy of your SF-50 "Notification of Personnel Action'', documenting your RIF separation, noting your positions, grade level, and duty location, and/or Agency certification of inability to place you through RPL, etc.;
- A copy of your latest performance appraisal including your rating; and
- Any documentation from your agency that shows your current promotion potential.
- Veterans Employment Opportunities Act (VEOA) documentation, if applicable. For more information, please go to https://www.fedshirevets.gov/job/shav/
- Documentation supporting eligibility for non-competitive appointment, (severely disabled, eligible veterans, certain military spouses, etc.)
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.
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. Learn more about federal benefits.
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 this position, you must complete the occupational questionnaire and submit the documentation specified in the Required Documents section below.
To receive consideration for this position you must submit a complete application (including all required documents) by 11:59 PM (ET) on the closing date of this announcement, which is 03/09/2018.
Instructions for applying to this job:
- To begin, click Apply. You must be logged into your USAJOBS account to apply. If you do not have a USAJOBS account, you will need to create one before beginning the application.
- After logging into your USAJOBS account, you will be taken to an online application which you must complete in order to apply for the position. *Verify the documents required for your application. Follow the prompts to select your USAJOBS resume and/or other supporting documents. You will have the opportunity to upload additional documents to include in your application.
- Complete the online questionnaire, include necessary supporting documents and submit your application using the Submit Application button. Your application package will not be processed unless you click Submit Application.
- To verify the status of your application, log into your USAJOBS account, https://my.usajobs.gov/Account/Login, select the Application Status link and select the More Information link for this position. The Application Status page will display the status of your application, the documentation received and processed, and your responses submitted to the online application. Your uploaded documents may take several hours to clear the virus scan process.
- To return to saved application at a later date, log into your USAJOBS account and click Update Application in the vacancy announcement. You must re-select your resume and/or other documents from your USAJOBS account or your application will be incomplete.
By submitting your application, you are certifying the accuracy of the information contained in your application. If you make a false statement in any part of your application, you may not be hired; you may be terminated after you begin work; or, you may be fined or jailed. After making a tentative job offer, we will conduct a suitability/security background investigation.
Agency contact information
Mid-Atlantic Services Branch
10903 New Hampshire Ave
Silver Spring, MD 20993
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. Once this process is completed, you will be notified of your status via e-mail.
You will be required to submit official documentation prior to appointment. The agency will then verify the information provided on your application (i.e., degree, veterans' preference, disability, etc.).
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.
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.
Legal and regulatory guidance
This job originated on www.usajobs.gov. For the full announcement and to apply, visit www.usajobs.gov/GetJob/ViewDetails/492153800. Only resumes submitted according to the instructions on the job announcement listed at www.usajobs.gov will be considered.