Aegis Ventures is seeking a 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.
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
- 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
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.
