FDA Fellowship - Development of Medical Device Extractable Database and Toxicological Risk Assessment Approaches
To submit your application, scroll to the bottom of this opportunity and click APPLY.
A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- One educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.CDRH@orau.org. Please include the reference code for this opportunity in your email.
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*Applications will be reviewed on a rolling-basis.
FDA Office and Location: Research opportunities are available within the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), located at Silver Spring, Maryland.
Research Project: Two project opportunities are available in the Biocompatibility/Toxicology program in the FDA Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL).
- Medical Device Extractable and Leachable Database Project: This project will offer the opportunity to develop databases of containing chemical s extracted from medical devices. The databases will contain chemical specific information including material of origin, physiochemical descriptors, toxicological thresholds and points of departure. The database will be created through data-mining of medical device submissions, and toxicological and chemical databases using Python coding and artificial intelligence-based approaches.
- Toxicological Evaluation of Medical Device Extractables and Establishing Risk Frameworks Project: This project will offer the opportunity to develop novel toxicological risk frameworks to evaluate medical device extractables. The project will analyze real data of medical device extractables to establish toxicology thresholds for medical devices.
Learning Objectives: Under the guidance of a mentor, you will gain experience in data analytics in a real-world setting and toxicological risk assessment of medical devices, as well as an understanding of regulatory science and medical device biocompatibility review processes.
Mentor: The mentor for this opportunity is Michael Eppihimer (Michael.Eppihimer@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.
Appointment Length: The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
The qualified candidate should be currently pursuing or have received a bachelor's, master's, or doctoral degree in the one of the relevant fields. Degree must have been received within the past five years, or be currently pursuing.
Preferred skills:
- Background in data science and/or computer programming with some understanding of chemistry and biology.
I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
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