Regulatory Scientific Reviewer; Biomedical Engineer ISO​/TS or ASTM F2182

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.

• a regulatory scientific reviewer (biomedical engineer) integrates engineering principles - spanning mechanical, electrical, chemical, and materials engineering 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.

• u.s. Citizenship requirement or proof of being a u.s. National must be met by closing date.
• selective service registration: all applicants born male, on (or after) 12/31/1959, must be registered with the selective service system or have an approved exemption. Visit (Use the "Apply for this Job" box below). for more info.
• fda participates in e-verify: all new hires must complete the i-9 form; this information will be processed through e-verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• background investigation requirement: all employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• you must meet all requirements by the closing date of this announcement to be considered. Only education, experience, and qualifications attained by this date will be considered. You must continue to meet all requirements through the hiring process.
• certification of accuracy: all information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• direct deposit: you will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within fda, through shared corporate recruiting activities.
• probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• financial disclosure may be required.
• ethics clearance may be required.

the position of regulatory scientific reviewer (biomedical engineer) falls under the 0858 occupational series. To qualify for this position at grade ad-00, you must meet all requirements by 11:59 pm est on 08/07/2026.

basic requirements: chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://-

• a. Degree: engineering. To be acceptable, the program must: (1) lead to a bachelor's degree in a school of engineering with at least one program accredited by abet; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven…