Director of Regulatory Affairs

Job description

**About Us** Epia Neuro is a neural technology company developing intent-driven systems designed to restore function and independence for people living with neurological conditions. Its platform integrates implantable neural interfaces, adaptive algorithms, and assistive devices to translate neural intent into real-world action. The company’s initial focus is stroke-related motor impairment, with expansion in cognitive decline and other neurological disorders, focusing on long-term solutions for the growing aging population. **The Role** We're looking for a Director of Regulatory Affairs, based in our Alameda, California office, to own the regulatory strategy and execution for Epia Neuro's Class III implantable neurotechnology - end-to-end, from early FDA engagement through IDE and PMA submission, approval, and commercialization. Reporting to the CEO, you'll be the one responsible for turning that strategy into results, not just defining it. **What You’ll Do** - Own the regulatory strategy from early feasibility through PMA approval and beyond, including pathway, milestones, and risk positioning, for a novel Class III implantable brain computer interface. - Serve as our primary interface with FDA and other regulators. You make the regulatory calls and carry the outcomes. - Lead submissions end to end: Breakthrough Device Designation, Q-Subs, IDE, and PMA deliverables. Hands-on with the content, in the trenches with the teams building the product. - Build the RA function from the ground up. Set direction, run external consultants, and stay in the work as the company scales. - Partner across the company during design and development (including software). You take part in decisions as they are made, not after the fact. **Qualifications** - 7+ years in medical device Regulatory Affairs, including 4+ in Class III and/or active implantable technologies. - Proven track record leading FDA interactions and submissions, including Pre-Submissions (Q-Subs), Breakthrough Device Designation, and/or IDEs. PMA experience preferred. - Ability to translate FDA regulations and ISO standards into actionable development and clinical plans. - Demonstrated experience owning regulatory strategy decisions in direct partnership with a multidisciplinary team during product development, including medical device software and algorithms under IEC 62304. - Regulatory experience supporting clinical studies, including protocol input, safety reporting, and IDE maintenance. - Strong technical writing. You will be drafting submission content, not just reviewing it. - Excited to operate in an early-stage environment, with the ability to build and scale processes while driving execution. - Strong working knowledge of quality systems and audits (internal, Notified Body, and/or FDA) in a Class III/active implantable environment, enough to partner effectively with our Quality function. - Degree in biomedical engineering, life sciences, or a related technical field. **Nice-to-Haves** - Experience working with implantable neurotechnology, whether BCIs or neuromodulation devices. - Direct hands-on audit or FDA inspection experience. - Prior experience at FDA, for example as a reviewer. - Understanding of the engineering principles behind implantable neurotechnology. **Location** This role is based out of the San Francisco Bay Area, and expected to work on site from our Alameda Headquarters minimum 3 days a week. **How We Work** - **We are intentional.** We prioritize and are thoughtful about how we use others’ time. - **We care for others.** We prioritize safety both for patients and one another. - **We own outcomes, not just tasks.** Our work demands the highest standards because it impacts real patients and real lives. - **Humility is a strength.** We are honest about what we know and what we don’t know. Getting it right matters more than being right. **Benefits** Full-time employees are eligible for the following benefits listed below. - Competitive base salary with equity - 100% of healthcare coverage for you and your dependents - Generous vacation policy - Paid parental leave - Work from our beautiful waterfront office in Alameda, CA, with access to collaborative spaces and labs.