VP, Regulatory Affairs & Quality Assurance

At Blackrock Neurotech, we’ve spent decades making the impossible possible – helping people move, speak, and reconnect with the world when they otherwise could not. We’ve seen that restoring function restores more than ability. It restores independence, identity, and agency.

Today, we are building the next generation of human capability: brain-computer interfaces that are designed to be safe, scalable, and trusted in the real world. Our work is not only about reconnecting people to what was lost, but about expanding what is possible – creating a seamless interface between human intent and technology.

This is foundational work in a category-defining field. You will help build the infrastructure for a future where neural interfaces are invisible, reliable, and deeply human-centered.

• Owning meaningful, high-impact problems at the frontier of science and engineering
• Building alongside experienced, thoughtful peers across disciplines
• Solving technically complex challenges grounded in real human outcomes
• Contributing to a culture that values rigor, clarity, and long-term thinking over noise

The Vice President, Regulatory Affairs & Quality Assurance will provide strategic and operational leadership across Blackrock Neurotech’s Regulatory Affairs and Quality Assurance functions. You will guide the regulatory strategy and quality systems that support the development, clinical advancement, regulatory approval, and commercialization of next-generation neurotechnology and implantable brain-computer interface products.

You will establish an integrated regulatory and quality strategy aligned with the company’s product development and business objectives, maintain a robust, scalable Quality Management System, and ensure compliance with applicable global requirements. You will provide executive oversight of Clinical Affairs, partnering with the Director to align clinical evidence and study milestones with regulatory requirements and product objectives.

As a member of the leadership team, you will partner closely with the CEO and leaders across R&D, Engineering, Clinical Affairs, Operations, and Commercial to assess current capabilities, establish clear priorities, and build the people, processes, and systems required to advance clinical milestones and support long-term commercialization.

You will operate with meaningful ownership in a high-consequence environment, contributing to systems that must be precise, reliable, and durable.

• Lead the path to approval and commercialization by defining and executing regulatory strategies for Blackrock’s neurotechnology and Class III implantable BCI products
• Build the quality foundation for scaleby assessing current capabilities and strengthening the systems and processes that support product development, clinical readiness, and reliable performance
• Provide executive oversight of Clinical Affairsby guiding clinical strategy, priorities, budgets, and resources, while supporting the Director of Clinical Affairs in leading study planning and execution
• Align clinical evidence with the path to approval by partnering with Clinical Affairs, scientific advisors, and clinical investigators to ensure study designs, endpoints, and evidence support regulatory submissions, product development, and commercialization
• Partner closely with Engineering, R&D, Clinical Affairs, and Operations to turn scientific and technical progress into products supported by clear evidence, sound risk decisions, and regulatory readiness
• Navigate complex regulatory decisions by bringing structured thinking to product pathways, development tradeoffs, and interactions with FDA, global regulators, and Notified Bodies
• Bu…