Senior QA/RA Specialist

About Optain

Optain is a revolutionary healthcare company that uses groundbreaking software and hardware technology to rethink care. We use the eye as a window to the body to improve the way we detect and manage eye and systemic conditions. Optain is committed to expanding and improving care through the introduction of AI and machine learning technology frontline care settings at an accessible price. This not only promotes greater access to care, but promises to reduce the strains of overburdened healthcare systems. Originally founded in Australia in 2019, Optain seeks to commercialize the inventions of Professor Mingguang He, a preeminent clinician-scientist and scholar in the field of ophthalmology. Optain has achieved regulatory approval and commercial adoption of its product suite in global markets, including Australia, Europe, and more. In 2025, Optain received US FDA clearance for its Resolve retinal camera. Optain also recently closed a Series A funding round led by Insight Partners with participation from seven leading U.S. health system investors, including Memorial Hermann Health System, Northwell Health, Novant Health, The Ohio State University Wexner Medical Center, and UPMC. These systems collectively deliver care to 28 million patients across 25 states and have begun deploying Optain's platform across their networks, rapidly accelerating the company's footprint and expanding screening access nationwide.

● About Optain

About the Job

We are seeking an experienced Senior QA/RA Specialist to own quality and regulatory operations for our US hardware product line and provide critical support across our expanding portfolio. This role will report to the Sr. Director of Quality Assurance and Regulatory Affairs and serve as the primary QA/RA lead for our US-marketed camera device, supporting all aspects of FDA compliance, supplier quality, and design controls while supporting our post-market activities. This position is essential to scaling our operations and ensuring we maintain the highest quality standards as we expand commercially and enter new markets.

This is a fully remote position based in the United States with up to 30% travel for site visits, training activities or company meetings. Occasional international travel may be required.

What You'll Do:

• Support regulatory strategy and submission timelines for US market
• Support management of medical device listing, establishment registration, and labeling compliance
• Own quality oversight of supplier relationships for US market
• Conduct supplier audits (remote and on-site) and manage audit findings to closure
• Lead CAPA investigations and effectiveness verification
• Manage incoming inspection criteria and supplier performance metrics
• Coordinate design transfer and manufacturing scale-up activities
• Maintain design control documentation (DHF) for hardware products
• Handle complaint investigations and MDR reporting
• Support document control and training record maintenance
• Partner with Engineering on design verification/validation protocols
• Work with Operations on manufacturing quality requirements
• Coordinate with Director of QA/RA on global compliance strategy

What You'll Need:

• 7+ years of medical device quality assurance and regulatory affairs experience
• Demonstrated experience supporting FDA 510(k) submissions
• Proven track record managing contract manufacturer relationships and supplier quality
• Experience conducting supplier audits and managing complex CAPA investigations
• Hands-on experience with design controls and DHF maintenance for Class II devices
• Expert knowledge of FDA regulations (21 CFR Part 820, Part 11, 510(k) pathway)
• Strong understanding of ISO 13485 quality management system requirements
• Proficiency in risk management per ISO 14971
• Working knowledge of design control requirements and V&V best practices
• Experience with complaint handling and MDR reporting
• Experience with hardware medical devices (optical devices, cameras, or imaging systems) is preferred
• Experience working with Asian contract manufacturers, particularly in China is preferred
• Background in both software and hardware medical device environments is preferred

What You'll Bring to the Table:

• Ability to work independently with minimal oversight and strong decision-making capability
• Excellent written and verbal communication skills for regulatory submissions and audits
• Strong project management skills with ability to manage multiple priorities
• Analytical mindset for root cause analysis and problem-solving
• Collaborative approach to working with engineering, operations, and international teams

Benefits & Perks:

• Competitive compensation package, including a strong base salary, performance-based bonus, and the chance to earn upside.
• Top-tier health, vision, dental, and commuter benefits.
• Generous monthly health and wellness reimbursement.
• Unparalleled exposure to new business building at the intersection of artificial intelligence and healthcare.
• The opportunity to help solve difficult problems and collaborate with world-class experts from healthcare provider networks, academia, and industry.
• A chance to work with a highly talented, close-knit team and world-leading mentors who can act as a support network and sounding board throughout your entrepreneurial journey.

Salary Range:

• $85,000 - $115,000 base salary, depending on experience and alignment with role expectations.

Why Optain?Make a real difference: Your work will help solve difficult problems as you collaborate with world-class experts from healthcare provider networks, academia, and industry. Join Optain in transforming healthcare with AI!