Senior QA/RA Specialist

Aegis Ventures

2d•$85,000 - $115,000•Remote

About The Position

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.

Requirements

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

Nice To Haves

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
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

Responsibilities

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

Benefits

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.

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