About this role
Job SummaryThis 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.
QualificationsIn 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 Requirements: 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. 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 quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities. OR Have a master's degree and have 3 years of comparable experience conducting quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities. OR Have a Doctorate and/or J.D. degree and have 1 year of comparable experience conducting quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities. OR Have a MD, DO, DDS, DPM, or DVM degree. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Major DutiesConducts quality and technical reviews of assigned premarket and post-market regulatory submissions to evaluate completeness, consistency, and compliance with applicable statutes, regulations, FDA guidance documents, and CDRH standard operating procedures. Reviews assigned medical device regulatory review activities and coordinates with CDRH offices to obtain information necessary to evaluate review documentation, processes, and compliance with applicable quality management standards, operating procedures, and regulatory requirements. Applies professional knowledge of health science, medical device regulation, and quality management principles to evaluate assigned review activities, methodologies, and documentation for consistency with established standards. Applies knowledge of medical device classification, regulatory pathways, including 510(k), De Novo, PMA, and HDE submissions, and applicable regulatory requirements when evaluating assigned regulatory review activities and supporting documentation. Collaborates with CDRH review staff and program offices to obtain technical information necessary to complete assigned quality assessments and ensure observations accurately reflect the scientific and regulatory context of the review activities evaluated. Conducts quality assessments of assigned organizational processes to evaluate conformance with CDRH's Quality Management System, ISO 9001:2015 requirements, applicable FDA regulations, and established procedures.