Vision Scientist

About the role

Tunnell Government Services, Inc., is comprised of the industry's leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals.

Responsibilities

• Conduct scientific and regulatory reviews to evaluate the safety and effectiveness of new ophthalmic devices.
• Review total product lifecycle actions (premarket, compliance, and post-market surveillance) related to ophthalmic devices.
• Apply technical expertise to determine the adequacy of methodology, protocols, and data concerning bench, animal, and/or clinical testing.
• Provide recommendations on submission clearance, approval, disapproval, or request additional information.
• Prepare comprehensive memos supporting the recommendation and, when required, prepare the appropriate correspondence to the applicant.
• Develop, modify, and evaluate guidelines concerning data required in medical device actions to be submitted to the Agency.
• Present reviews, conclusions, opinions, and recommendations to appropriate scientific review panels on PMAs, petitions for reclassification, etc.
• Collaborate with other scientists to better understand medical device problems.
• Stay updated on 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

• Solid background in basic and/or clinical visual psychophysics, visual optics, and optical instrumentation.
• 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.
• Experience in the manufacture, quality control, validation/verification testing of ophthalmic optical devices.
• Expertise in critically reviewing scientific documents and clear communication of review results.
• Desirable technical experience in Visual Neuroscience, Neuroanatomy and neurophysiology of the retina and visual pathways, Visual electrophysiology, Functional imaging of visual pathways, Optics of the eye, and Low Vision.
• 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 acceptable.
• Minimum of 10 years' experience in fields directly relevant to the Vision Scientist position.
• Experience authoring and evaluating responses to and from Regulatory Agencies.

Benefits

This position is 100% telework. Must be a US Citizen or full Green card holder.