Review Scientist (Staff Fellow)
Introduction: 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 are safe and effective. The mission of CDRH is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. OHT7 is responsible for the in vitro diagnostic, radiological health, and mammography quality standards programs. DRH is responsible for review of radiation therapy, MRI, , diagnostic X-ray, nuclear medicine, mammography, ultrasound and imaging software devices, as well as radiation-emitting electronic products (e.g., lasers, microwave products, UV products).
Meet one of the faces behind CDRH here.
Position Summary: OHT7/DRH is recruiting candidates with strong radiation oncology expertise (hardware, software, and radionuclide dosimetry); diagnostic radiology imaging experience (hardware and software including Artificial Intelligence and Machine Learning); and/or experience with radiation safety of electronic products.
Duties/Responsibilities: The Review Scientist performs the following duties:
- Apply clinical, engineering, and scientific principles under a well-established regulatory framework for evaluating the safety and effectiveness of medical devices and electronic products throughout their product life cycle.
- Maintain awareness of radiological devices and radiation emitting products, and their manufacturers.
- Understand the use conditions and risks to health posed by medical devices and electronic products.
- Provide regulatory and public health guidance to consumers, patients, professionals, and manufacturers.
- Complete radiological public health projects under the guidance of Assistant Directors, Division Directors, and other senior managers.
Basic Qualifications: Applicants must meet the specific qualification requirements of the following applicable occupational series: Bioengineering and Biomedical Engineering (0858), General Engineering (0801), Physics (1310), Biologist Series (0401), Chemistry Series (1320), Diagnostic Radiologic Technologist (0647), Therapeutic Radiologic Technologist (0648), Computer Science (1550)
Beneficial Specialized Experience and Qualifications: The following experience, while not all required, would be beneficial for successful applicants.
- Knowledge of regulatory affairs, clinical affairs or clinical trials management.
- Therapeutic or medical imaging device research and development or clinical experience in hospital, clinic, or oncology treatment centers.
- Experience with managing public health projects/initiatives related to radiological health.
- Ability to effectively manage multiple assignments under strict deadlines.
- Exceptional analytical skills (qualitative and quantitative).
- Ability to effectively communicate analyses to various audiences verbally and in writing.
Additional Qualifications:
To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).
Conditions of Employment:
- One-year probationary period may be required.
- This position is for a two-year appointment and will be filled through FDA’s Staff Fellowship Program
- Background and/or Security investigation required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
- 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.
How to Apply: Prior to applying, please see the following instructions:
- Documents to submit: electronic resume or curriculum vitae and cover letter describing why you are uniquely qualified for this job.
- Compile all applicant documents into one combined document (i.e. Adobe PDF)
- Include Job Reference code “DRH Review Scientist” in the email subject line.
- Email applicant package to CDRHRecruitment@fda.hhs.gov
HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.