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Tunnell has a contract opportunity available supporting the Division of Ophthalmic Devices (DOD) within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration. A Vision Scientist is needed to conduct scientific and regulatory reviews to evaluate the safety and effectiveness of new ophthalmic devices. This is a remote position.

DOD serves as the primary source for scientific and medical expertise on ophthalmic medical devices with regard to safety and effectiveness. The Division carries out scientific and end-to-end medical device review evaluation, including, coordinating and making premarket review determinations, as well as, planning and coordinating post market compliance and enforcement efforts related to medical devices.

Duties of the Vision Scientist may include but are not limited to:

• With guidance and direction from senior scientist and engineers, the reviewer will review total product life-cycle actions (premarket, compliance, and post-market surveillance) related to ophthalmic devices. Actions may include 510(k)s, PMAs, De Novos, IDEs, pre-submissions, submission issue requests, 513(g)s, recalls and complaint submissions. Reviewer will apply his/her technical expertise to determine the adequacy of methodology, protocols and data concerning bench, animal and/or clinical testing and will, as needed, obtain appropriate consultation reviews of methodology, protocols and data that are outside the scope of the reviewer's expertise. Based on a collective evaluation of the submission, the reviewer will provide a recommendation of submission clearance, approval, disapproval, request additional information or provide scientific and/or regulatory feedback to applicants. For each submission, the reviewer will prepare a comprehensive memo supporting the recommendation and, when required, prepare the appropriate correspondence to the applicant.
• Assist with the developing, modifying, and evaluating guidelines concerning data required in medical device actions to be submitted to the Agency. In this capacity, the reviewer participates as a member of a team of experts to develop agency or center-wide guidelines applicable to the regulation of relevant medical devices.
• Present reviews, conclusions, opinions, and recommendations to appropriate scientific review panels on PMAs, petitions for reclassification, etc. These presentations will include key issues pertaining to the safety and effectiveness of the medical device(s), outlines of deficiencies, and recommendations for approval or non-approval of the device or the submission.
• Enhance professional career development by collaborating with other scientists to better understand medical device problems. Keep abreast of current events and findings and changes in medical device law and regulations through review of scientific and legislative literature, personal contact with relevant authorities, and by attending scientific meetings.

Qualifications:

The candidate should have a solid background in basic and/or clinical visual psychophysics, visual optics, and optical instrumentation as evidenced by a record of independent, peer-reviewed published research.

Background and experience in optics, optical design software and manufacturing optical test equipment as evidenced by education and relevant work history is desired.

A highly qualified candidate will have research experience with human participants including clinical trial design and management, especially clinical research involving ophthalmic devices (e.g., surgical lasers, imaging devices, diagnostic visual tests, ocular implants). Experience in the manufacture, quality control, validation/ verification testing of ophthalmic optical devices (e.g., intraocular lenses and contact lenses) is desired. Expertise in critically reviewing scientific documents and skill in clearly communicating review results are essential. Background in the following technical area(s) is highly desirable:

• Visual Neuroscience

• • Neuroanatomy and neurophysiology of the retina and visual pathways
  • Visual electrophysiology, both clinical (ERG, VEP, etc.) and basic (single & multi-cell recording, retinal/LGN/cortical circuitry, electrical stimulation of visual pathways)
  • Functional imaging of visual pathways (e.g., functional MRI, opto-genetics, fluorescence)

• Optics of the eye

• • Sources of retinal scattered light and its effects on retinal image quality in fovea and periphery
  • Retinal image quality (resolution and contrast) as a function of eccentricity
  • Optics of photoreceptors

• Light hazard analysis, and mechanisms of light damage to the eye.
• Low Vision
• Clinical psychophysical & optical testing

• • contrast sensitivity,
  • low contrast acuity,
  • mesopic acuity,
  • perimetry,
  • color vision testing,
  • stereopsis, binocular vision
  • pupillometry,
  • aberrometry
  • accommodation testing
  • light & dark adaptation
  • psychophysical methodology

• Doctoral level degree (e.g., Ph.D., M.D., D.O.) in a relevant field is preferred; however, a M.S. in Life Sciences/Engineering discipline combined with extensive experience with ophthalmic devices may also be
• Minimum of 10 years' experience in fields directly relevant to the Vision Scientist position.
• Experience authoring and evaluating responses to and from Regulatory Agencies is desired.
• Demonstrated capability of proficient written and oral communication

This position is 100% telework.

Must be a US Citizen or full Green card holder.