# Director of Regulatory Affairs and Quality Assurance

**Company:** [Eightsleep](https://hotfix.jobs/companies/eightsleep)
**Location:** San Francisco, CA
**Role:** Other
**Experience:** 8+ years
**Skills:** Fda 510(K), De Novo, Iso 13485, Iso 14971, Risk Management, Quality Management System, Regulatory Affairs, Post-Market Surveillance, Cross-Functional Program Management
**Posted:** 2026-07-15

> Lead risk management, regulatory submissions (FDA 510(k), De Novo), and quality systems (ISO 13485/14971) for medical device sleep technology. Requires 8+ years in medical device QA/RA, successful FDA clearances, and cross-functional leadership with R&D and Clinical teams.

## Job Description

## 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 & Benefits
Every 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

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