VP, Regulatory Affairs & Quality Assurance

The Role

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.

What You'll Do

• 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 scale by assessing current capabilities and strengthening the systems and processes that support product development, clinical readiness, and reliable performance
• Provide executive oversight of Clinical Affairs by 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
• Build and empower a capable QA/RA team by defining the organizational structure, hiring key talent, and establishing clear ownership as the company grows
• Shape executive decisions and drive execution by translating quality and regulatory priorities into actionable plans that advance near-term milestones and long-term commercialization

What You Bring

• Bachelor’s degree in engineering, life sciences, or a related discipline with 12+ years of relevant medical device experience, or a master’s degree with 10+ years of relevant experience
• Senior leadership experience across Quality and Regulatory Affairs, including partnering with executive leadership on product development, risk, and commercialization decisions
• Demonstrated experience taking Class III implantable medical devices through regulatory approval and commercialization, with direct ownership of quality or regulatory milestones
• Experience leading FDA regulatory interactions and submissions for implantable devices, including IDE and PMA programs, and working with international regulators and Notified Bodies
• Strong working knowledge of ISO 13485, ISO 14971, FDA quality system requirements, and EU MDR, with the ability to apply clinical investigation requirements to regulatory strategy
• Demonstrated understanding of medical device clinical development and investigations, including study design, endpoints, evidence generation, and clinical study requirements, sufficient to provide executive oversight and align clinical programs with regulatory and commercialization objectives
• Demonstrated experience building and leading a team from the ground up, including defining the organizational structure, hiring key talent, and establishing the processes and infrastructure needed to scale
• Experience strengthening or restructuring functions in a small or growing medical device organization, with the judgment to adjust resources as priorities evolve
• Ability to operate strategically while remaining close to the work, communicate clear expectations, and guide teams through complex decisions under time pressure
• Experience with BCI, DBS, intracortical recording or stimulation, neuroprosthetics, or other neuro-implantable technologies is a plus
• Familiarity with MasterControl or comparable electronic quality management systems is preferred

How We Work

We are a small, experienced team working on consequential problems.

• We take ownership of outcomes and follow through with clarity and accountability
• We prioritize sustained, high-quality work over performative urgency
• We value rigor, sound judgement and thoughtful decision-making
• We collaborate deliberately: low ego, high trust and high context
  
  

This is a high-ownership role, but it is not an "always-on" one. We expect strong work and our people to have a life outside of it.

Working Location:

Making Salt Lake City, UT your home base is ideal, however, we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

Build the systems that expand human capability

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.

Working at Blackrock Neurotech means:

• 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