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
• Two educational or professional references
All documents must be in English or include an official English translation.
If you have questions, send an email to FDArpp@orau.org. Please include the reference code for this opportunity in your email.
An opportunity is available at the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) in Silver Spring, Maryland.
The Software Precertification (Pre-Cert) Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan [PDF], will help inform the development of a regulatory model to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.
The FDA envisions that the future regulatory model will provide more streamlined and efficient regulatory oversight of software-based medical devices developed by manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the U.S. market. This proposed approach aims to look first at the software developer and/or digital health technology developer, rather than primarily at the product, which is what we currently do for traditional medical devices. Because software products can be adapted to respond to glitches, adverse events, and other safety concerns quickly, the FDA is working to establish a regulatory framework that is equally responsive when issues arise to help ensure consumers continue to have access to safe and effective products. In the Pre-Cert program, the FDA is proposing that software products from precertified companies would continue to meet the same safety and effectiveness standard that the agency expects for products that have followed the traditional path to market.
The learning objectives of this training will include:
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 initial appointment is for five months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at FDA in the Silver Spring, Maryland, area. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
The Homeland Security Presidential Directive-12 (HSPD-12) mandates a background check be completed for both U.S. Citizens and foreign nationals. Foreign nationals must have resided in the U.S. for at least three (3) of the past five (5) years in order for FDA to be able to complete a background check.
Desired Appointment Start Date: November 15, 2018
The qualified candidate should be a current student or postgraduate in data science, computer science, electrical engineering, software engineering or biomedical engineering. Degrees must have been received within five years of the appointment start date.
Familiarity with the software development life cycle is desired.
Preferred skills:
I have received a bachelor's, master's or doctoral level degree within the past five years, or are currently pursuing a bachelor's, master's or doctoral degree.
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Question: What do I need to submit an application?
Answer: Typically, applicants are required to submit a resume or CV, an official copy of their transcripts or academic record, and a minimum of two references at the time they apply. Additional requirements such as a writing sample, thesis or dissertation, etc. may be required. Review the opportunity details for additional information about the requirements for applying for an opportunity.
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Question: Can a family member serve as a reference?
Answer: No; family members may not serve as references. References must be able to speak to your educational and/or professional experience. At least one academic reference is preferred.
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