Vision Scientist

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Perform scientific and regulatory evaluations of ophthalmic device submissions throughout the entire product life cycle, encompassing premarket, compliance, and post-market surveillance actions.

• Assess 510(k)s, PMAs, De Novos, IDEs, pre-submissions, submission issue requests, 513(g)s, recalls, and complaint submissions.

• Analyze the sufficiency of methodologies, protocols, and data derived from bench, animal, and clinical testing.

• Seek consultation reviews when submissions exceed the reviewer’s area of expertise.

• Suggest submission clearance, approval, disapproval, requests for further information, or scientific/regulatory feedback.

• Draft detailed review memoranda and correspondence with applicants.

• Aid in the development, modification, and assessment of agency guidelines regarding medical device data requirements.

• Deliver reviews, conclusions, opinions, and recommendations to scientific review panels.

• Work collaboratively with scientists to address medical device issues.

• Remain updated on medical device laws, regulations, scientific literature, and legislative changes.

⛳️ Requirements

• Strong foundation in basic and/or clinical visual psychophysics, visual optics, and optical instrumentation, demonstrated through independent, peer-reviewed published research.

• Research experience involving human participants, including clinical trial design and management, particularly in clinical studies related to ophthalmic devices.

• Proficiency in critically evaluating scientific documents and effectively communicating review findings.

• Background in visual neuroscience, covering neuroanatomy and neurophysiology of the retina and visual pathways; visual electrophysiology; and functional imaging of visual pathways.

• Understanding of the optics of the eye, retinal scattered light, retinal image quality, and photoreceptor optics.

• Familiarity with light energy hazard analysis and the mechanisms of light damage to the eye.

• Knowledge of causes of low vision and rehabilitation strategies.

• Experience in clinical psychophysical and optical testing, including contrast sensitivity, BCVA, mesopic acuity, perimetry, color vision testing, stereopsis, pupillometry, aberrometry, accommodation testing, light and dark adaptation, and psychophysical methodology.

• A doctoral-level degree in a relevant field is preferred; an M.S. in Life Sciences/Engineering with substantial relevant experience may also be acceptable.

• A minimum of 5–10 years of experience in areas directly related to the Vision Scientist position.

• Experience in authoring and assessing communications with Regulatory Agencies is preferred.

• Proven proficiency in both written and verbal communication.

• Must be a U.S. Citizen or possess a full Green Card.

🏝️ Benefits

• Employee-owned company.

• 100% telework / remote work.