Regulatory Scientific Reviewer (Biomedical Engineer)
Food and Drug AdministrationThis 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.A Regulatory Scientific Reviewer (Biomedical Engineer) integrates engineering principles - spanning mechanical, electrical, chemical, and materials engineering - with biological and medical sciences to analyze, design, and evaluate medical devices, diagnostic systems, and biomedical technologies. Applies biomechanical, biocompatibility, and systems engineering methods to assess product performance, safety, and fitness for use in clinical and biological environments. Bridges engineering and medicine to provide the rigorous technical expertise required to evaluate devices and technologies intended for use in the diagnosis, treatment, or monitoring of human health conditions. Analyzes complex data and guidelines or criteria for scientific review and approval for a class of products. Identifies risks, gaps, trends, and reviews or coordinates review of important precedent setting scientific issues which establish Agency policy for subsequent reviews of similar products.
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