Vision Scientist

About the Role

Tunnell Government Services, Inc. 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.

Responsibilities

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

• With guidance and direction from senior scientists and engineers, review total product life-cycle actions (premarket, compliance, and post-market surveillance) related to ophthalmic devices, including 510(k)s, PMAs, De Novos, IDEs, pre-submissions, submission issue requests, 513(g)s, recalls and complaint submissions.
• Apply technical expertise to determine the adequacy of methodology, protocols and data concerning bench, animal and/or clinical testing and, 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, provide a recommendation of submission clearance, approval, disapproval, request additional information or provide scientific and/or regulatory feedback to applicants.
• For each submission, prepare a comprehensive memo supporting the recommendation and, when required, prepare the appropriate correspondence to the applicant.
• Assist with developing, modifying, and evaluating guidelines concerning data required in medical device actions to be submitted to the Agency, including participating 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., including key issues pertaining to safety and effectiveness, 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 and 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.

Highly Qualified Candidate

• Research experience with human participants including clinical trial design and management, especially clinical research involving ophthalmic devices (e.g., surgical lasers - cornea and retina, functional and diagnostic imaging devices, diagnostic visual tests, ocular implants such as intraocular lenses and retinal prosthetics).
• Experience in the manufacture, quality control, validation/verification testing and measures for prescription 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.

Desired Technical Background

• 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 energy hazard analysis, and mechanisms of light damage to the eye
• Low Vision causes (medical conditions leading to impaired vision) and rehabilitation
• Clinical psychophysical & optical testing: contrast sensitivity (typical luminance and low luminance), BCVA (best corrected visual acuity) and low contrast acuity, mesopic acuity, perimetry, color vision testing, stereopsis, binocular vision, pupillometry, aberrometry, accommodation testing, light & dark adaptation, psychophysical methodology

Education and Experience

• Doctoral level degree (e.g., Ph.D., M.D., D.O.) in a relevant field is preferred; however, an M.S. in Life Sciences/Engineering discipline combined with extensive experience with vision science and ophthalmic devices may also be considered.
• Minimum of 5-10 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.

This response is AI-generated, for reference only.