Job Opportunity: Scientific Reviewer – Staff Fellow, FDA Respiratory Devices Team – Silver Spring, MD
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
OHT-1 is responsible for the regulatory oversight of ophthalmic, anesthesia, respiratory, ear, nose and throat (ENT) and dental devices and encompasses a wide spectrum of medical technologies. The Respiratory Devices Team within OHT-1 is responsible for regulating several types of medical products including ventilators and accessories, pulmonary diagnostic devices, drug delivery devices including nebulizers and metered dose/dry powder inhalers (MDIs/DPIs), pulmonary surgical devices including oncologic treatment, bronchoscope accessories, surgical sealants, Software as a Medical Device (SaMD) submissions including ML/AI applications for respiratory diagnostics and treatment management, among others.
Staff fellows encourage and promote research/regulatory review, studies, and investigations related to health. Related health areas include medical, physical, biological, mathematical, biometric, epidemiological, behavioral, and computer sciences directly related to the mission of the Agency. As a Scientific Reviewer (Staff Fellow) in OHT-1, you will review and analyze scientific data submitted to the FDA in support of OHT1’s mission to ensure the safety and effectiveness of new and existing respiratory devices.
These duties include:
- Utilize knowledge and experience to inform scientific and regulatory decisions regarding the safety and effectiveness of new and existing respiratory devices as an integral member of multidisciplinary review teams
- Prepare oral and written communications of review recommendations
- Effectively communicate within FDA, with device manufacturers, and with other public health stakeholders
- Advance expert knowledge and keep abreast of latest scientific trends, technologies, and techniques related to areas of expertise.
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office.
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience and knowledge regarding the evaluation and/or development of respiratory devices (ventilatory devices, pulmonology devices) is desirable.
- Desirable background could include training or experience with regulatory affairs, medical device development and regulation, quality systems, or medical device evaluation (risk analysis, biocompatibility, software development, usability, or mechanical/material/biomedical/electrical/software engineering).
- All candidates are expected to have a strong commitment to public health.
- Must be a United States Citizen or resident alien.
- Documents to submit: electronic resume or curriculum vitae, cover letter describing why you are uniquely qualified for this, and copy of transcripts
- Compile all applicant documents into one combined document (i.e., Adobe PDF)
- Include Job Reference code “RPDT Scientific Reviewer“ in the email subject line.
- Email applicant package to RespiratoryDevicesTeam@fda.hhs.gov