Epicareer Might not Working Properly
Learn More

Biomedical Engineer

  • Full Time, onsite
  • Food and Drug Administration
  • Anywhere in the U.S. (remote job), United States of America
Salary undisclosed

Apply on

Availability Status

This job is expected to be in high demand and may close soon. We’ll remove this job ad once it's closed.


Original
Simplified
  • This position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), Office of Product Evaluation and Quality, Office of Regulatory Programs (ORP). This is a remote position.
  • ORP develops policy and provides support across all regulatory programs conducted within OPEQ.
  • ORP performs cross-cutting analysis to assess the performance of programs, develops tools that aid in evaluating the safety and quality of devices and electronic products, and continually monitors the state of regulated industry.
  • ORP programs strive to amplify and improve the impact that Center activities have on patients by facilitating accurate, consistent and timely assessment of medical and other technology over its full life.
  • ORP staff provide programmatic expertise; develop regulatory policy, processes, and tools; provide interpretations of regulatory requirements; and address novel or complex policy exceptions encountered during reviews.
  • Staff conduct program analysis and quality control activities for programs for purposes of ensuring consistency across OPEQ components and continually improving upon CDRH regulatory programs.
  • ORP also provides technical and logistical support on document control and automated systems which support the review activities performed across OPEQ and CDRH.
  • As a Senior Scientist in the ORP, you will develop regulatory programs and policies development for entities across CDRH engaged in the review of medical devices and radiological products;
  • Apply knowledge of scientific methodology and the application of science to ensure scientific consistency and validity of policy-related documents; and
  • Serve as a subject matter expert in legal, regulatory, and scientific matters related to the review and authorization of medical devices and electronic products.
Starting at $104,604 Per Year (GS 14)