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 D.
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 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. -OR- 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. -OR- 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. -OR- 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.
Major DutiesLeads independent quality and technical reviews of submissions to assess the quality, completeness, and compliance of submissions in accordance with applicable procedures, regulations, and CDRH guidance documents. Leads audits and assessments of post-market surveillance review activities and documents findings to identify trends or deficiencies that may indicate systemic quality issues within CDRH's review programs. Reviews medical device product activities with broad coordination across CDRH to assess alignment with established quality management standards, regulatory requirements, and applicable operating procedures and regulations. Applies advanced health science knowledge and regulatory expertise to assess the adequacy of CDRH review activities, methodologies, and procedures, identifying areas where review quality may be strengthened or where deviations from established standards have occurred. Independently reviews and evaluates CDRH premarket and post-market review decision activities to ensure consistency with applicable statutory requirements, FDA guidance, and established review standards. Applies expert knowledge of medical device classification, regulatory pathways (including 510(k), De Novo, PMA, and HDE), and applicable performance standards to evaluate and provide senior-level guidance on the regulatory determinations made during CDRH review activities. Collaborates with and provides senior-level guidance to CDRH review staff and program offices to gather information necessary to conduct quality assessments of regulatory review activities, ensuring that findings are grounded in an accurate and comprehensive understanding of the scientific and regulatory context of each review area. Independently leads quality assessments and compliance evaluations of CDRH's core, organizational, and enabling processes to determine conformity with internal quality management standards, ISO 9001:2015 requirements, and applicable FDA regulations and policies. Leads continuous process improvement (CPI) initiatives by independently identifying inefficiencies in CDRH review and compliance processes, developing evidence-based solutions, and directing the implementation and evaluation of process changes in collaboration with relevant stakeholders. Leads and participates in cross-functional working groups and committees focused on quality management, regulatory review improvement, and operational excellence, contributing authoritative subject matter expertise in health science and regulatory compliance.