Biologist

Full Job Description

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624.

The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.

This position is being recruited based on the Title 21 Pay Table 1, Band C.

In order to qualify for the Biologist position which falls under the 0401 occupational Series, you must meet the following requirements by 11:59 pm EST on 04/07/2026: Basic Qualification Requirements: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/0400/general-natural-resources-management-and-biological-sciences-series-0401/ A.

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

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

Minimum Qualifications: Comparable experience is experience that equipped the applicant with the knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.

The comparable experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience).

Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations.

AND IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS: Have a bachelor's degree and have 4 years of comparable experience conducting regulatory reviews of medical device submissions applying biological expertise to evaluate product safety and effectiveness, served as subject matter expert providing technical consultation, contributed to policy development, and communicated scientific concepts to diverse stakeholders.

OR Have a master's degree and have 3 years of comparable experience conducting regulatory reviews of medical device submissions applying biological expertise to evaluate product safety and effectiveness, served as subject matter expert providing technical consultation, contributed to policy development, and communicated scientific concepts to diverse stakeholders.

OR Have a Doctorate degree and have 1 year of comparable experience conducting regulatory reviews of medical device submissions applying biological expertise to evaluate product safety and effectiveness, served as subject matter expert providing technical consultation, contributed to policy development, and communicated scientific concepts to diverse stakeholders.

OR Have a MD, DO, DDS, DPM, or DVM degree.

OR Have 6 years of comparable experience conducting regulatory reviews of medical device submissions applying biological expertise to evaluate product safety and effectiveness, served as subject matter expert providing technical consultation, contributed to policy development, and communicated scientific concepts to diverse stakeholders.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Major Duties:

Conducts and leads regulatory reviews spanning the full product lifecycle.

Serves as a senior technical authority to Center and industry scientists regarding a variety of medical and radiological health products.

Contributes to the development of new review practices, policies, guidance documents and regulations within areas of knowledge or expertise.

Prepares and delivers presentations to medical and scientific experts in various professional settings.