Director of Clinical Affairs — Regulatory Trials Leader

Eight Sleep, Inc.; San Francisco (CA); On-site; USD 200,000 - 250,000; Full time

Benefits offered by this job

Equity participation

Pod access

Health insurance

Job summary

Eight Sleep is seeking a Director of Clinical Affairs to own end-to-end regulatory-driven clinical studies for FDA-regulated medical devices and SaMD/digital health products. This hands-on role requires standing up studies, managing sites, IRB/ICF documents, data management, and regulatory submissions.

You'll bridge internal teams with CROs, IRBs, and regulatory bodies, ensuring on-time, on-budget delivery while maintaining high standards of compliance and research integrity in a fast-paced

Qualifications

• 10+ years in clinical operations with FDA-regulated devices or SaMD/digital health.
• Experience leading cross-functional teams and clinical programs.
• Proven track record of IRB/ethics submissions and regulatory submissions.
• Strong budgeting, vendor management, and CRO oversight skills.

Responsibilities

• Lead study design and ensure trials lead to clearance, coverage, and ramp.
• Own protocol development through final report, site activation, enrollment, monitoring, and close-out.
• Write and manage IRB submissions, informed consent forms, and essential documents.
• Oversee third-party sites and investigators to ensure protocol compliance and data quality.
• Manage clinical data operations and vendor relationships with CROs and data managers.
• Collaborate with regulatory, product, engineering, and legal for submission timelines and strategy.

Skills

Clinical operations

FDA regulations

Leadership

Budgeting

Vendor management

IRB submissions

Education

Bachelor's degree

Advanced degree preferred

Job description

Eight Sleep is seeking a Director of Clinical Affairs to own end-to-end regulatory-driven clinical studies for FDA-regulated medical devices and SaMD/digital health products. This hands-on role requires standing up studies, managing sites, IRB/ICF documents, data management, and regulatory submissions.

You'll bridge internal teams with CROs, IRBs, and regulatory bodies, ensuring on-time, on-budget delivery while maintaining high standards of compliance and research integrity in a fast-paced