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.
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.
What You’ll Do
- Serve as the company's regulatory authority and primary interface with regulatory bodies, owning regulatory decisions and outcomes, not solely managing the relationships.
- Set the regulatory direction for the organization and own its execution - building the RA function's processes and structure from the ground up, and staying hands-on as the team scales.
- Define and own the global regulatory strategy, setting the path from early feasibility through PMA approval, including key milestones, risks, and regulatory positioning.
- Partner directly with engineering on design and software decisions during active development, not reviewing after the fact, and help cross-functional alignment across development, clinical, quality, and operations to ensure activities support the regulatory strategy and requirements.
- Lead the execution of regulatory submissions end-to-end, driving the development of BDD, Q-Subs, IDE, and PMA deliverables through hands-on leadership and strong cross-functional coordination.
Qualifications
- 7+ years of experience in Regulatory Affairs for medical devices.
- 4+ years of experience 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.
- Deep understanding of applicable FDA regulations and ISO standards with the ability to translate them into actionable development and clinical plans.
- Demonstrated experience owning regulatory strategy decisions in direct partnership with engineering during active development, including software/SOUP risk classification.
- Comfortable operating in early-stage environments, 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 help grow our Quality function.
- Degree in biomedical engineering, life sciences, or a related technical field (advanced degree preferred).
Nice-to-Haves
- Experience working with implantable neurotechnology (BCIs and/or Neuromodulation devices).
- Startup or small company experience Prior experience at the FDA (e.g., as a reviewer).
- Direct hands-on audit experience is a plus.
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.
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.