Director of Regulatory Affairs

Epia Neuro; Alameda; On-site; CAD 264,000 - 388,000; Full time

Benefits offered by this job

Competitive salary with equity

Excellent healthcare coverage for you

Generous vacation policy

Paid parental leave

On-site Alameda office

Job summary

Epia Neuro, based in the San Francisco Bay Area with Alameda headquarters, seeks a Director of Regulatory Affairs to lead global regulatory strategy for Class III implantable neurotechnology. You will own FDA engagements, IDEs and PMA submissions, and drive regulatory execution across development, quality and operations.

Working closely with leadership, you will build scalable regulatory processes, influence milestones, and ensure timely approvals to bring transformative neural technologies to

Qualifications

• 7-9 years of regulatory affairs experience for medical devices.
• 4+ years in Class III and/or active implantable technologies.
• Proven track record leading FDA interactions and submissions.
• Deep understanding of applicable FDA regulations and ISO standards.
• Strong communicator and collaborator across technical and non-technical teams.
• Experience in early-stage environments and scaling regulatory processes.

Responsibilities

• Serve as regulatory authority and primary interface with regulators, guiding regulatory outcomes.
• Define and own global regulatory strategy from feasibility through PMA approval, including milestones and risks.
• Lead end-to-end regulatory submissions (BDD, Q-Subs, IDE, PMA) with hands-on leadership.
• Drive cross-functional alignment across development, clinical, quality, and operations.
• Set regulatory direction for the organization while remaining involved in high-impact areas.

Skills

Regulatory strategy

FDA interactions

Regulatory submissions

Cross-functional leadership

Project management

Communication skills

Early-stage development

Education

Biomedical engineering or life sciences

Advanced degree preferred

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 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.

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, 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.

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.