PDF versionJob Summary
This position is being filled through the Direct Hire Authority for this occupation and is open to all US Citizens. All applicants who meet the basic and minimum qualification requirements will be forwarded to the Selecting Official for consideration This position is located in the Center of Devices and Radiological Health in Silver Spring, MD. Additional selections may be made within the same geographical area FDA-wide.
Major Duties
- Works closely with senior level reviewers in the review and evaluation of scientific data submitted to the FDA by medical device industry to determine safety and efficacy of routine and non-complex medical device products.
- Serves as a consultant and advisor to scientific and technical personnel inside and outside the agency in a wide-ranging arena of scientific subject matters to include the field of medical devices and/or radiological product analysis and methods.
- Conducts and participates in discussions with industrial scientists and management officials regarding the development and regulation of medical devices.
- Writes and evaluates guidelines concerning the data required in submissions to the Agency for medical devices and their marketing.
- Develops, modifies, and evaluates guidelines concerning data required in device actions submitted to the Agency for medical devices.
Qualifications
BASIC QUALIFICATIONS:
In order be eligible for the position of Biologist, (GS-0401-11/12/13), you must meet the following requirements... In order to qualify as Biologist, GS-0401-11, you must meet the following: A. Have a degree in biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position. - OR - B. Have a combination of education and experience -- courses equivalent to a major in biological sciences, agriculture, natural resource management, chemistry or related disciplines appropriate to the position. (You must submit your transcript(s) that demonstrates this coursework at time of application submission). - AND- MINIMUM QUALIFICATIONS REQUIREMENTS:
C. GS-11: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-09) in the Federal service conducting studies and investigations concerning biological, chemical, and/or physical processes that affect biology resources; writing reports that provide recommendations for change or improvement; and analyze conventional biological issues. OR Have 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree. GS-12: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-11) in the Federal service developing scientific experiments, conducting biological studies/investigations and following established experimental protocols or developing new experimental/ biologic protocols; interpreting scientific and regulatory directives to provide recommendations to other scientists; and preparing synopsis of data. GS-13: Applicants must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-12) in the Federal service providing scientific expertise of review biological experimentation processes; serving as an expert to provide technical advice for complex, scientific tests, investigate environmental/ biological conditions and/or protocols to develop new techniques; and analyzing scientific data to evaluate ecobiological/ biological conditions and preparing synopsis of data submitted; and interpreting scientific directives to provide recommendations to other scientists. 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 through this announcement. Candidates will be referred as Commissioned Corps personnel and not as candidates for conversion to a permanent career or career-conditional appointment. All qualification requirements must be met by 11:59 pm (Eastern Time) on 11/07/2019. If, after reviewing your resume and/or supporting documentation, a determination is made that you have inflated your responses when compared to your background information, you may be deemed ineligible or your score may be adjusted to more accurately reflect your skills and abilities.
Pay Range
$69,581.00 - $128,920.00