Role DescriptionSleep 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
Compensation & BenefitsEvery role at Eight Sleep includes competitive compensation and benefits. Final compensation will depend on experience, location, and level.
Benefits may include:
- 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 - and other great benefits
- Every Eight Sleep employee receives the very product that defines our mission: a Pod of their own. If you join us you'll get your own Pod.
