Director of Regulatory Affairs
Epia Neuro, California, MO, United States
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 for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology.
As a Director of Regulatory Affairs you will report to the Chief Executive Officer and be responsible for owning the regulatory strategy and execution end‑to‑end from early FDA engagement through IDEs and PMA submission and approval, and commercialization.
What You’ll Do
Serve as the company’s regulatory authority and primary interface with regulatory bodies, leading interactions and influencing regulatory outcomes.
Define and own the global regulatory strategy, setting the path from early feasibility through PMA approval, including key milestones, risks, and regulatory positioning.
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.
Drive cross‑functional alignment across development, clinical, quality, and operations to ensure activities support the regulatory strategy and requirements.
Set the regulatory direction for the organization while remaining close to execution, building structure where needed, and maintaining direct involvement in high‑impact areas.
Qualifications
Degree in biomedical engineering, life sciences, or a related technical field (advanced degree preferred).
7‑9 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.
Strong communicator and collaborator with the ability to work effectively across technical and non‑technical teams.
Comfortable operating in early‑stage environments, with the ability to build and scale processes while driving execution.
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).
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.
Full‑time employees are eligible for the following benefits listed below.
Benefits
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.
#J-18808-Ljbffr
The Role We’re looking for a Director of Regulatory Affairs for our office in Alameda, California who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class III implantable neurotechnology.
As a Director of Regulatory Affairs you will report to the Chief Executive Officer and be responsible for owning the regulatory strategy and execution end‑to‑end from early FDA engagement through IDEs and PMA submission and approval, and commercialization.
What You’ll Do
Serve as the company’s regulatory authority and primary interface with regulatory bodies, leading interactions and influencing regulatory outcomes.
Define and own the global regulatory strategy, setting the path from early feasibility through PMA approval, including key milestones, risks, and regulatory positioning.
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.
Drive cross‑functional alignment across development, clinical, quality, and operations to ensure activities support the regulatory strategy and requirements.
Set the regulatory direction for the organization while remaining close to execution, building structure where needed, and maintaining direct involvement in high‑impact areas.
Qualifications
Degree in biomedical engineering, life sciences, or a related technical field (advanced degree preferred).
7‑9 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.
Strong communicator and collaborator with the ability to work effectively across technical and non‑technical teams.
Comfortable operating in early‑stage environments, with the ability to build and scale processes while driving execution.
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).
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.
Full‑time employees are eligible for the following benefits listed below.
Benefits
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.
#J-18808-Ljbffr