General Health Scientist

U.S.-Food-and-Drug-Administratio; Hillandale (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

The U.S. Food and Drug Administration in Maryland seeks a General Health Scientist to join the CDRH team.

The role requires leading independent quality assessments, audits, and compliance evaluations of FDA review activities, applying judgment to identify improvement opportunities and corrective actions. Applicants must have a relevant health sciences degree and meet specific experience requirements by the stated deadline.

Qualifications

• Bachelor's degree or higher in health sciences from an accredited program.
• Applicants must submit transcripts to prove education.
• Experience: 5y (Bachelor), 4y (Master), 2y (Doctorate/JD/MD) leading quality assessments.

Responsibilities

• Lead independent quality assessments, audits, and compliance evaluations of CDRH review activities.
• Apply authoritative judgment to identify improvement opportunities and deficiencies.
• Develop corrective action recommendations and track closures per FDA standards.

Skills

Quality assessments

Audits

Compliance evaluations

Regulatory requirements

Quality management

Education

Bachelor's degree or higher in health sciences

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 Title 21 Pay Table 1, Band D. In order to qualify for the General Health Scientist position which falls under the 0601 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/16/2026:

Basic Qualification Requirement

Education: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

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

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 five (5) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a Master's degree and have four (4) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a Doctorate/or JD degree and have two (2) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a MD, DO, DDS, DPM, or DVM degree and have two (2) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.