Chemist

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 Chemist position which falls under the 1320 occupational Series, you must meet the following requirements by 11:59 pm EST on 04/07/2026: Basic Qualification Requirements: Education: A bachelor's degree or higher in chemistry, biochemistry, or chemical engineering.

OR A bachelor's degree or higher in physical sciences, life sciences, or engineering, plus appropriate experience in chemistry. Note: The degree must be from an accredited program or institution.

Minimum Qualifications: Relevant 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 specialized 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 serving as a senior chemist providing scientific support for regulatory and compliance activities involving medical devices and radiological products by obtaining and reviewing technical data and materials related to scientific analysis projects.

OR Have a master's degree and have 3 years of comparable experience serving as a senior chemist providing scientific support for regulatory and compliance activities involving medical devices and radiological products by obtaining and reviewing technical data and materials related to scientific analysis projects.

OR Have a Doctorate and/or J.D.

degree and have 1 year of comparable experience serving as a senior chemist providing scientific support for regulatory and compliance activities involving medical devices and radiological products by obtaining and reviewing technical data and materials related to scientific analysis projects.

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

OR Have 6 years of comparable experience serving as a senior chemist providing scientific support for regulatory and compliance activities involving medical devices and radiological products by obtaining and reviewing technical data and materials related to scientific analysis projects.

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

Reviews scientific data submitted in support of medical device submissions such as pre-market applications (PMAs), product development protocols (PDPs), applications for investigational device exemptions (IDEs), and premarket notifications.

Serves as an expert technical consultant and advisor to scientific and technical personnel inside and outside the agency in the field of medical devices and radiological product analysis.

Researches and evaluates policy issues central to CDRH's mission in chemistry, develops and modifies guidelines concerning data required in device and recommends improvements to regulatory review or compliance enforcement processes.

Designs and conducts experimental and theoretical studies to evaluate the performance of medical devices and radiological products, develops new or modifies existing methods to evaluate new products.

Collaborates with other scientists, engineers, healthcare professionals, and other professionals in CDRH, FDA, and outside FDA on scientific and regulatory issues and coordinates matters relating to emergency preparedness and response.