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

Hiring organization: [Eight Sleep](https://career.thegoodapps.co/organizations/eight-sleep)

Canonical page: https://career.thegoodapps.co/jobs/4b81a714-4671-41d0-9f22-a783f32b6918

Listed on Eight Sleep's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Director
- Location: San Francisco, CA

## Summary

Eight Sleep is hiring a Director of Regulatory Affairs and Quality Assurance to lead compliance, risk management, and FDA regulatory strategy for their medical-device sleep technology platform. This role suits experienced medical device professionals ready to shape regulatory practices at a growth-stage company with direct access to leadership and R&D.

_Our summary, not Eight Sleep's wording._

## Skills named

ISO 13485, Quality Management Systems, Risk Management

## Required

- 8+ years of quality function experience in medical devices
- Successful FDA clearance track record (510(k) or De Novo)
- Cross-functional program management expertise
- Experience with ISO 13485 and ISO 14971 compliance standards
- Bachelor's degree or equivalent

Apply on Eight Sleep's site: https://jobs.ashbyhq.com/eightsleep/8d3c53d3-8ee0-4aa4-b45b-5e5b942d414a/application