Vision Scientist

Tunnell Government Services•Bethesda, MD

11d•Remote

About The Position

Tunnell Government Services, Inc. is seeking a Vision Scientist to support the Division of Ophthalmic Devices (DOD) within the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration. This is a remote position where the Vision Scientist will conduct scientific and regulatory reviews to evaluate the safety and effectiveness of new ophthalmic devices. The DOD is the primary source for scientific and medical expertise on ophthalmic medical devices regarding safety and effectiveness, carrying out scientific and end-to-end medical device review evaluations, including coordinating premarket review determinations and planning post-market compliance and enforcement efforts.

Requirements

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.
Expertise in critically reviewing scientific documents.
Skill in clearly communicating review results (written and oral communication).
Minimum of 10 years’ experience in fields directly relevant to the Vision Scientist position.
Must be a US Citizen or full Green card holder.

Nice To Haves

Background and experience in optics, optical design software, and manufacturing optical test equipment.
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).
Background in Visual Neuroscience.
Background in Neuroanatomy and neurophysiology of the retina and visual pathways.
Background in Visual electrophysiology, both clinical (ERG, VEP, etc.) and basic (single & multi-cell recording, retinal/LGN/cortical circuitry, electrical stimulation of visual pathways).
Background in Functional imaging of visual pathways (e.g., functional MRI, opto-genetics, fluorescence).
Background in Optics of the eye.
Background in Sources of retinal scattered light and its effects on retinal image quality in fovea and periphery.
Background in Retinal image quality (resolution and contrast) as a function of eccentricity.
Background in Optics of photoreceptors.
Background in Light hazard analysis, and mechanisms of light damage to the eye.
Background in Low Vision.
Background in Clinical psychophysical & optical testing.
Background in contrast sensitivity.
Background in low contrast acuity.
Background in mesopic acuity.
Background in perimetry.
Background in color vision testing.
Background in stereopsis, binocular vision.
Background in pupillometry.
Background in aberrometry.
Background in accommodation testing.
Background in light & dark adaptation.
Background in psychophysical methodology.
Experience authoring and evaluating responses to and from Regulatory Agencies.

Responsibilities

Conduct scientific and regulatory reviews of 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.
Obtain appropriate consultation reviews for methodology, protocols, and data outside the reviewer’s expertise.
Provide recommendations for submission clearance, approval, disapproval, request additional information, or provide scientific and/or regulatory feedback to applicants based on collective evaluation of the submission.
Prepare comprehensive memos supporting recommendations and appropriate correspondence to applicants.
Assist with developing, modifying, and evaluating guidelines concerning data required in medical device actions submitted to the Agency.
Participate 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.
Enhance professional career development by collaborating with other scientists to understand medical device problems.
Stay informed about current events, findings, and changes in medical device law and regulations through literature review, personal contact, and attending scientific meetings.