Senior QA/RA Specialist
85k - 115k USD
Remote
Full Time
#Artificial Intelligence
#Health Care
#Medical Devices
#FDA Compliance
#Management
#Design
#ISO 13485
#ISO
#Risk Management
#Reporting
We are looking for a Senior QA/RA Specialist to join our team in a full-time, remote capacity. At Optain, we are revolutionizing the healthcare landscape by utilizing advanced software and hardware to transform how eye and systemic conditions are managed. As a company backed by Aegis Ventures and recently cleared by the FDA for our Resolve retinal camera, we are rapidly scaling our footprint across major U.S. health systems. In this role, you will take ownership of quality and regulatory operations for our hardware product line, ensuring we maintain the highest standards while expanding our commercial reach.
Responsibilities
- Lead regulatory strategy and manage compliance for our U.S. market, including device listings, establishment registrations, and labeling requirements.
- Oversee supplier quality by conducting audits, managing performance metrics, and ensuring all findings are brought to a successful closure.
- Drive critical quality processes such as CAPA investigations, design control maintenance for our hardware products, and mandatory MDR reporting.
Requirements
- At least 7 years of experience in quality assurance and regulatory affairs within the medical device industry.
- Proven expertise in FDA 510(k) submissions, 21 CFR Part 820 regulations, and ISO 13485 standards.
- Strong background in managing design controls, risk management per ISO 14971, and supplier quality oversight.
- Preferred: Experience working with hardware imaging systems and contract manufacturers in Asia.
What we offer
We provide a competitive annual base salary ranging from $85,000 to $115,000, determined by your specific experience and alignment with our goals.
- Comprehensive medical, dental, and vision insurance plans.
- Commuter benefits to support your travel needs.
- The flexibility of a fully remote work environment.
- The opportunity to collaborate with world-class experts at the intersection of artificial intelligence and healthcare.
