Interdisciplinary Scientist

Duties

• Serve as a senior level lead reviewer, reviewing and conducting complex evaluations or reviews.
• Lead the review of a wide range of various cardiovascular medical device products.
• Serve as the scientific or engineering lead in the review of Premarket Notifications (510(k)s), Investigational Device Exemptions (IDEs) and Premarket Approvals (PMAs) in developing rulemakings, guidance documents and other policy documents.
• Integrate in-depth scientific and/or engineering knowledge with applicable laws, regulations and policies.
• Advise Division and Office management on issues related to engineering/scientific subject matter and provide verbal and written responses related to those cardiovascular medical device products.
• Provide verbal and written conclusions to other Federal agencies, industry, universities and State and local governments, etc.
• Collaborate extensively with stakeholders within and outside FDA.

Qualifications

Basic Requirements for the GS-401 series, Biologist:

Degree: biological sciences, agriculture, natural resource management, chemistry, or related disciplines appropriate to the position.
OR

Combination of education and experience--Courses equivalent to a major, as shown above, plus appropriate experience or additional education.

Basic Requirements for the GS-403 series, Microbiologist:

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.
OR
Combination of education and experience--courses equivalent to a major in microbiology, biology, chemistry, or basic medical science that included courses as shown above, plus appropriate experience or additional education.

Basic Requirements for the GS-1320 series, Chemist:

Degree: 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.

OR

Combination of education and experience -- course work equivalent to a major as shown 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.

AND

In addition to the basic qualification requirement, you must also meet the following:

Have one year of specialized experience, equivalent to the GS-13 in the Federal service, serving as a scientific or engineering reviewer, or senior advisor in the area of medical device evaluation as it relates to the review and evaluation of premarket notification submissions, premarket applications and/or investigational device exemptions for premarket approval prior to entry into the marketplace.
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.

Education

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.