VP, Regulatory Affairs & Quality Assurance

Blackrock Neurotech • Salt Lake City, UT

8h • Remote

About The Position

The Vice President, Regulatory Affairs & Quality Assurance provides strategic and operational leadership across Blackrock Neurotech’s Regulatory Affairs and Quality Assurance functions. The role guides regulatory strategy and quality systems supporting the development, clinical advancement, regulatory approval, and commercialization of neurotechnology and Class III implantable brain-computer interface products.

The VP establishes an integrated regulatory and quality strategy aligned with product development and business objectives, maintains a robust and scalable Quality Management System, and ensures compliance with applicable global requirements. The role also provides executive oversight of Clinical Affairs, partnering with the Director of Clinical Affairs to align clinical evidence and study milestones with regulatory requirements and product objectives.

As a member of the leadership team, the VP partners closely with the CEO and leaders across R&D, Engineering, Clinical Affairs, Operations, and Commercial. The role assesses current capabilities, establishes priorities, and builds the people, processes, and systems needed to advance clinical milestones and support long-term commercialization. It is a high-ownership role in a high-consequence environment, focused on precise, reliable, and durable systems.

Requirements

• 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 organizational structure, hiring key talent, and establishing processes and infrastructure needed to scale.
• Experience strengthening or restructuring functions in a small or growing medical device organization, with 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.

Nice To Haves

• Experience with BCI, DBS, intracortical recording or stimulation, neuroprosthetics, or other neuro-implantable technologies.
• Familiarity with MasterControl or comparable electronic quality management systems.

Responsibilities

• Define and execute regulatory strategies for neurotechnology and Class III implantable BCI products to support approval and commercialization.
• Assess current quality capabilities and strengthen systems and processes supporting product development, clinical readiness, and reliable performance.
• Provide executive oversight of Clinical Affairs, guiding clinical strategy, priorities, budgets, and resources while supporting the Director of Clinical Affairs with study planning and execution.
• Partner with Clinical Affairs, scientific advisors, and clinical investigators to align study designs, endpoints, and evidence with regulatory submissions, product development, and commercialization.
• Collaborate with Engineering, R&D, Clinical Affairs, and Operations to translate scientific and technical progress into products supported by clear evidence, sound risk decisions, and regulatory readiness.
• Guide complex regulatory decisions concerning product pathways, development tradeoffs, and interactions with FDA, global regulators, and Notified Bodies.
• Build and empower the QA/RA team by defining its structure, hiring key talent, and establishing clear ownership as the company grows.
• Translate quality and regulatory priorities into actionable plans, inform executive decisions, and drive execution toward near-term milestones and long-term commercialization.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive