Director Of Regulatory Affairs And Quality Assurance (Medtech)

TL;DR

Director of Regulatory Affairs and Quality Assurance (Medtech): Leading risk management and quality systems to navigate FDA submissions and ensure compliance for medical-grade sleep technology. Focus on building regulatory strategy, managing cross-functional clinical and R&D alignment, and overseeing post-market monitoring to enable life-saving product capabilities.

Location: Must be based in San Francisco (Onsite)

Company

hirify.global is the world's first sleep fitness company, building advanced hardware, software, and AI technology to optimize human performance through data-driven recovery.

What you will do

• Shape and lead risk management practices across the organization.
• Provide strategic regulatory guidance and lead the company through FDA submissions (510(k), De Novo).
• Oversee compliance and documentation practices to meet medical device standards.
• Collaborate with R&D, Clinical, and Operations teams to accelerate product approvals.
• Implement and manage comprehensive post-market monitoring workflows.

Requirements

• 8+ years of industry experience in quality functions for medical devices.
• Successful track record of FDA clearance (510(k), De Novo).
• Experience establishing and monitoring compliance to ISO 13485 and ISO 14971.
• Exemplary cross-functional program management skills.
• Bachelor’s degree or equivalent experience.

Culture & Benefits

• Competitive salary and equity packages.
• Full access to health, vision, and dental insurance for employees and dependents.
• Flexible PTO and paid parental leave.
• Supplemental life insurance.
• Employee discount on products and a complimentary Pod for every employee.
• Team offsites and company events.