Senior Director, Regulatory Affairs-CA (Medical Devices)

Location: San Diego, California, US; onsite

Salary: $210,000–$240,000 annually, plus potential discretionary bonuses and/or equity grants.

Company

hirify.global develops non-surgical brain–computer interfaces designed to restore digital interaction for people with paralysis and support autonomy for people with cognitive decline.

What you will do

• Lead regulatory strategy and submission planning for software, firmware, and hardware used in new BCI platforms and product updates.
• Author and manage IDE, PMA, and PMA supplement submissions to the FDA, supporting international filings as needed.
• Develop regulatory strategies for complex medical-device software and firmware, including AI/ML features, change management, and lifecycle documentation.
• Partner with engineering, software, quality, clinical, and operations teams from early development through commercialization.
• Provide regulatory support for manufacturing changes, design transfers, product concepts, design inputs, roadmaps, and risk assessments.
• Monitor FDA regulations and international standards, manage compliance obligations, and represent hirify.global in FDA meetings and agency correspondence.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field; an advanced degree is preferred.
• 12+ years of regulatory affairs experience in the medical-device industry with progressive responsibility.
• Experience with complex, high-risk Class III active implantable neurological or cardiac devices.
• Strong software and firmware regulatory expertise, including AI/ML-enabled features, change management, and applicable FDA guidance.
• Independent experience leading IDE, PMA, and supplement submissions and managing agency interactions.
• Deep knowledge of 21 CFR Parts 820, 812, and 814, design controls, risk management, manufacturing changes, and design transfers.
• Visa sponsorship is not available for this position.

Nice to have

• RAC certification from RAPS.
• Experience with brain–computer interfaces, neural stimulation, or implantable neurotechnology.
• Familiarity with OUS regulatory pathways such as CE Mark or TGA.
• Experience scaling a regulatory function at a growth-stage medical-device company.

Culture & Benefits

• Cross-functional work in a lean, startup-style environment focused on collaboration and innovation.
• Minimal travel expected, under 10% of working time.
• Medical and dental insurance for eligible US W-2 full-time exempt employees and dependents.
• Life insurance, short- and long-term disability coverage, 401(k), discretionary unlimited PTO, and FSA.
• Commuter benefits are available for New York employees.