Senior QA/RA Specialist

Aegis Ventures(14 days ago)

RemoteFull TimeSenior$85,000 - $115,000Quality Assurance & Regulatory Affairs

About this role

Senior QA/RA Specialist at Optain, a medical device company commercializing an FDA-cleared retinal camera and AI-enabled screening platform. The role is positioned within the Quality Assurance & Regulatory Affairs function supporting the US hardware product line during commercial expansion. This is a fully remote US-based position reporting to the Senior Director of QA/RA with periodic travel for site visits and meetings.

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Required Skills

FDA Compliance
510(k) Submissions
Supplier Quality
Supplier Audits
CAPA Management
Design Controls
DHF Maintenance
Complaint Handling
MDR Reporting
ISO 13485

+5 more

About Aegis Ventures

aegisventures.com

Aegis Ventures is a New York City–based venture studio that partners with entrepreneurs and health systems to launch and scale healthtech startups. They combine investment with hands‑on operational support, product and go‑to‑market execution, and access to clinical and health‑system partners. The firm focuses on outcomes‑driven digital health and care‑delivery innovations that move healthcare forward. Aegis leverages deep healthcare relationships to de‑risk commercialization and accelerate adoption across provider networks.