Director of Clinical Affairs (Medical Devices)

Location: Hybrid, Boston Area or San Francisco, United States

Salary: $200,000–$250,000 base salary, plus equity and performance-based incentives

Company

hirify.global develops hardware, software, and AI technology for personalized sleep fitness and data-driven recovery.

What you will do

• Lead clinical study design and execution from feasibility and protocol development through enrollment, monitoring, close-out, and final study reporting.
• Manage third-party clinical sites, investigators, CROs, vendors, study committees, timelines, budgets, and risk mitigation plans.
• Write and manage IRB/Ethics submissions, informed consent forms, protocols, and essential study documentation.
• Oversee clinical data operations, including CRF/eCRF design, data review, query resolution, and database lock activities.
• Support FDA interactions, pre-submissions, 510(k) submissions, breakthrough device activities, audits, and other regulatory correspondence.
• Build and scale the clinical operations function through SOPs, templates, tracking systems, and repeatable processes.

Requirements

• 10+ years of hands-on clinical operations experience, including at least 5 years in leadership roles.
• Experience executing clinical studies for FDA-regulated medical devices, SaMD/digital health products, or combination products.
• Track record of supporting FDA clearances, approvals, or meaningful labeling expansions through clinical trials.
• Strong knowledge of FDA device regulations, ICH-GCP, ISO 14155, and applicable SaMD guidance.
• Experience with clinical data management, site oversight, CRO management, budgeting, vendor management, and reporting of adverse events and device deficiencies.
• Bachelor's degree required; advanced degree in a relevant field preferred.

Nice to have

• Experience with biosensing devices, consumer health technology, or wellness platforms.
• Familiarity with real-world evidence studies and decentralized or hybrid clinical trial models.
• Experience in a high-growth startup or scale-up environment.
• Experience supporting FDA breakthrough device designations or pre-submission meetings.
• ACRP or SOCRA certification.

Culture & Benefits

• High-intensity, performance-focused environment with substantial ownership and responsibility.
• Equity participation for full-time employees, including potential performance-based refreshes.
• Health, vision, and dental insurance for employees and dependents.
• Employees receive an hirify.global Pod and access to additional company perks.