Job Title:Consumer Safety Technician
Department:Department Of Health And Human Services
Agency:Food and Drug Administration
Job Announcement Number:PH-NM-14-982938
This position is closed and no longer accepting online applications through USAJOBS.
The contents of the announcement can still be viewed.
/ Per Year|
|Monday, October 28, 2013 to
Friday, November 01, 2013|
SERIES & GRADE:
|Full Time -
|Few vacancies -
Silver Spring, MD View Map|
WHO MAY APPLY:
|United States Citizens |
The Food and Drug Administration - Protecting and Promoting Your Health
Help protect public health by joining the FDA's Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
One or more positions may be filled using this vacancy announcement.
- You must be a U.S. Citizen or National.
- Resume and supporting documents (See How To Apply section)
DUTIES:Back to top
As a Consumer Safety Technician, you will be responsible for:
- Performing administrative-legal reviews of Investigational Device Exemptions (IDE), Pre-Market Approval (PMA), etc. submissions after scientific review and prior to final endorsement by the Division Director;
- Reviewing routine device submissions, supplements, and amendments to ensure they comply with regulatory requirements;
- Coordinating the review of IDEs and PMAs with the review team by setting up meetings and ensuring that time goals are reached; and
- Preparing a variety of reports and correspondence which relate to the submission and review of IDEs, PMAs and related supplements, including Freedom of Information Act requests
QUALIFICATIONS REQUIRED:Back to top
In order to be qualified for this position, you must possess one year of specialized experience equivalent to the GS-07 level in the Federal service reviewing various medical device submissions (i.e. 510(k)s, Investigational Device Exemptions, Pre-market Approval applications, etc.) for completeness and compliance with established policies, laws, and/or Standard Operating Procedures; tracking and coordinating workflow for a team to ensure work products are completed on schedule; gathering information for and coordinating the response to technical questions about policies, laws, and regulations; and using a variety of office automation equipment to prepare technical reports, memos, and other communications.
In addition, you must be able to type at least 40 words per minute with three or fewer errors based on a five minute sample.
Only experience obtained by the closing date of this announcement will be considered.
HOW YOU WILL BE EVALUATED:
Once the application process is complete, a review of 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. Qualified candidates will be assigned to a quality category: Best Qualified, Well Qualified, or Qualified. (Although veterans do not receive additional points, veterans' preference is still applied by placing them ahead of non-preference eligible within each category. Preference eligible who meet the minimum qualification requirements and who have a compensable service-connected disability of at least 10 per cent must be listed in the highest quality category (except in the case of scientific or professional positions at the GS-09 level or higher). The category assignment is a measure of the degree in which your background matches the competencies required for this position. Your qualifications will be evaluated on the following competencies (knowledge, skills, abilities and other characteristics):
- Knowledge of the Federal Food, Drug, and Cosmetic Act and related regulations
- Written Communication
- Oral Communication