General Health Scientist

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.

Major duties

Conducts 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.

Qualifications

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 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.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.