Director of Regulatory Affairs and Quality Assurance (RA / QA)

About the role

Sleep is inherently tied to health, and we have an immense opportunity to leverage our Pod platform to detect medical conditions and to provide therapy. We are looking for a Director of Regulatory Affairs and Quality Assurance to help build a business around this opportunity. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies. This role will interact closely with R&D, Clinical, and the executive team. Your work will improve the lives of numerous users and will enable our core mission of improving sleep and saving lives. This role is based out of our offices in San Francisco.

How you’ll contribute

• Shape risk management practices for the organization
• Provide regulatory input and guide the company through multiple submissions
• Oversee compliance and documentation practices
• Collaborate with R&D, Clinical, and Operations to accelerate approvals
• Implement and manage comprehensive post-market monitoring workflows

What you need to succeed

• 8+ years of industry experience in quality functions for medical devices
• Successful track record of FDA clearance (510(k), De Novo)
• Exemplary at cross-functional program management
• Experience establishing and monitoring compliance to relevant standards (e.g., ISO 13485, ISO 14971)
• Bachelor's degree or equivalent experience

Why join Eight Sleep?

• Innovation in a culture of excellence – Join us in a workplace where innovation isn't just encouraged - it's a standard. Our flagship product, the Pod, is a testament to our culture of excellence, beloved by hundreds of thousands of customers worldwide. At Eight Sleep, you will be part of a team that continuously pushes the boundaries of technology in sleep fitness.
• Immediate responsibility and accelerated career growth – From your first day, you'll take on substantial responsibilities that have a direct impact on our core business and product success. We are a small team that empowers you to own your projects and see the tangible effects of your efforts, enhancing both your professional growth and our company's trajectory. Your path will be challenging but rewarding, perfect for those who thrive in fast-paced environments aiming for high standards.
• Collaboration with exceptional talent – Work alongside other bright minds like you: at Eight Sleep exceptional intelligence and a passion for breakthroughs are the norms. Our team members are not only experts in their fields but also avid innovators who thrive in our dynamic, fast-paced environment.
• Equitable compensation and continuous equity investment – We extend equity participation to every full-time team member, recognizing and rewarding your direct contributions to our success. This includes periodic equity refreshments based on performance, ensuring that as Eight Sleep grows and succeeds, so do you – perfectly aligning your achievements with the broader triumphs of the company.

Benefits

• Full access to health, vision, and dental insurance for you and your dependents
• Supplemental life insurance
• Flexible PTO
• Commuter benefits to ease your daily commute
• Paid parental leave
• Your own Pod (every employee receives the product that defines our mission)