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This position is located in the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Surveillance and Biometrics (OSB), Division of Postmarket Surveillance (DPS), Medical Device Reporting Policy Branch in Silver Spring, Maryland.
This vacancy is also being announced concurrently with vacancy announcement FDA-FDA-17-MP-1980567MB under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures.
NOTE: Applicants must apply separately for each announcement in order to be considered.
Who May Apply: Open to all United States Citizens.
Additional selections may be made within the same geographical area FDA-wide.
- Not Required
In order to qualify for a Lead Microbiologist, GS-0403-14, you must meet the following:
A. Degree: microbiology; or biology, chemistry, or basic medical science that included at least 20 semester hours in microbiology and other subjects related to the study of microorganisms, and 20 semester hours in the physical and mathematical sciences combining course work in organic chemistry or biochemistry, physics, and college algebra, or their equivalent.
B. Combination of education and experience: courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown in A above, plus appropriate experience or additional education.
You must have one (1) year of specialized experience which is equivalent to at least the GS-13 grade level in the Federal service which includes developing and executing a microbiological study to evaluate the safety of medical devices; coordinating and managing the work assigned to a team of medical device reviewers, and monitoring and recording post-market performance issues related to regulated medical devices.
If you are claiming education as any part of your qualifications for this position, you must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. 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. For further information, click on foreign education.
Conditions of Employment:
- Security and Background Requirements: 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 hired, a background security reinvestigation or supplemental investigation may be required at a later time. Applicants are also advised that all information concerning qualifications is subject to investigation. False representation may be grounds for non-consideration, non-selection or appropriate disciplinary action.
- E-Verify: 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. Federal law requires DHS to use the E-Verify System to verify employment eligibility of all new hires, and as a condition of continued employment obligates the new hire to take affirmative steps to resolve any discrepancies identified by the system. The U.S. Department of Health and Human Services is an E-Verify Participant.
- Direct Deposit: 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. Note: This statement does not imply nor guarantee an incentive will be offered and paid. Incentives include the following: moving expenses, recruitment or relocation incentive; student loan repayment, superior qualifications appointment, creditable service for annual leave for prior non-federal work experience or prior uniformed military service, etc.
- Bargaining Unit Position: No
- All qualification requirements must be met by the closing of the announcement.
- Financial disclosure statement required: Yes
Please be advised that this position will be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position.
Q - Nonsensitive
If selected for this position, you will:
- Serve as the team leader and principal advisor to the Branch Chief on matters related to postmarket surveillance evaluations and guidance to medical device reporters on criteria to report adverse events, methods and procedures used in preparing summaries of experience reports, and reviewing evidence to support Center enforcement actions;
- Develop and carry out complex, far-reaching studies such as, analyzing the impact of the medical device regulation in providing safer and more effective medical devices which may impact other offices within the Center;
- As the recognized authority and team leader in the area of scientific and regulatory expertise, receives for resolution unique, far reaching, and previously unresolved problems involved with scientific and regulatory analysis;
- Lead, serve as a member, or recommend team members to represent the team on task forces and study groups called to consider problems or directions in postmarket surveillance.