Senior Advisor, Regulatory and Clinical Affairs
Core
Guide regulatory and clinical strategies to ensure successful commercialization of ophthalmic device products in the US, acting as a subject matter expert for FDA interactions and clinical research design.
Role type
Senior Advisor, Regulatory and Clinical Affairs (Medical Device)
Builds
US market approvals for ophthalmic devices (510k, PMA, IDE)
Domain
Medical Technology / Ophthalmology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulatory strategy, clinical research study design, standards development (ANSI), SOP development, product claim substantiation, audit support, FDA liaison
Preferred skills
Ophthalmology thought leadership, refractive surgery expertise, IOL technology knowledge, statistical analysis, prior FDA agency experience
Technologies
None stated
Responsibilities
Provide input to regulatory and clinical strategies for US market products; Participate in strategy meetings to provide Agency perspective; Design and implement complex clinical strategies; Coach organizations on US requirements; Review product claims for substantiation; Prepare and participate in meetings with US FDA; Conclude on adequacy of promotional materials; Support product complaint investigations and BIMO audits; Drive resolutions of FDA questions
Seniority
Senior, hands-on IC with strategic oversight
