Senior Director, Regulatory Affairs-CA (Medical Devices)

Location: San Diego, California — onsite full-time, 5 days per week. Minimal travel expected, under 10%.

Base salary: $210,000–$240,000 annually, depending on experience, skills, and qualifications. Discretionary bonuses and/or equity grants may also be available.

Company

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

What you will do

• Lead regulatory strategy and submission planning for software, firmware, hardware, new product development, and product updates.
• Author and manage IDE, PMA, and PMA supplement submissions to the FDA, while supporting international filings as needed.
• Develop regulatory strategies for complex BCI devices, including AI/ML features, software and firmware change management, and lifecycle documentation.
• Partner with engineering, software, quality, clinical, operations, and manufacturing teams from early development through commercialization.
• Monitor FDA regulations, guidance, and international standards for Class III implantable devices and software-driven medical technologies.
• Represent hirify.global in FDA meetings, pre-submission interactions, agency correspondence, and compliance activities.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related field; an advanced degree is preferred.
• At least 12 years of regulatory affairs experience in the medical device industry, including progressive responsibility for complex, high-risk Class III active implantable neurological or cardiac devices.
• Strong software and firmware regulatory expertise for complex medical devices, including AI/ML-enabled features, change management, and applicable FDA guidance.
• Experience independently leading FDA IDE, PMA, and supplement submissions and managing agency interactions.
• Knowledge of manufacturing-related regulatory requirements, design controls, risk management, process changes, design transfers, and new product development.
• Deep knowledge of 21 CFR Parts 820, 812, and 814, along with applicable international standards and strong communication skills.

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

• Lean, startup-style environment focused on collaboration, innovation, and safety-critical healthcare technology.
• Subsidized medical and dental insurance for US full-time employees and dependents.
• Life insurance, short- and long-term disability coverage, 401(k), and flexible spending accounts.
• Discretionary unlimited paid time off and commuter benefits for New York employees.
• US W-2 employment only; visa sponsorship is not available.