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

Eight Sleep • San Francisco, CA

3d • Onsite

About The Position

Sleep is inherently tied to health, and Eight Sleep has an immense opportunity to leverage its Pod platform to detect medical conditions and to provide therapy. 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 the company and regulatory agencies. This role will interact closely with R&D, Clinical, and the executive team. The work will improve the lives of numerous users and will enable the core mission of improving sleep and saving lives. This role is based out of the company's offices in San Francisco.

Requirements

• 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

Responsibilities

• 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

Benefits

• Competitive salary and equity
• Full access to health, vision, and dental insurance for you and your dependents
• Supplemental life insurance
• Flexible PTO
• Paid parental leave
• Team offsite and company events
• Employee discount on Eight Sleep products
• Opportunity to work with a world-class team building category-defining technology
• Your own Pod

What This Job Offers

• Job Type: Full-time
• Career Level: Director