VP, Regulatory Affairs & Quality Assurance

Blackrock Neurotech • Salt Lake City, UT

22d

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 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 works closely with the CEO and leaders across R&D, Engineering, Clinical Affairs, Operations, and Commercial. The role assesses current capabilities, sets priorities, and builds the people, processes, and systems needed to advance clinical milestones and support long-term commercialization. It carries meaningful ownership in a high-consequence environment where systems must be precise, reliable, and durable.

Salt Lake City, Utah is the ideal home base, but remote work will be considered. Remote employees are expected to make regular on-site visits for routine work and departmental events. The company describes the role as high-ownership but not “always-on,” and emphasizes sustained, high-quality work and life outside work.

Requirements

• Bachelor’s degree in engineering, life sciences, or a related discipline with 12 or more years of relevant medical device experience, or a master’s degree with 10 or more years of relevant experience.
• Senior leadership experience across Quality and Regulatory Affairs, including partnership 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, and ability to apply clinical investigation requirements to regulatory strategy.
• 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.
• Experience building and leading a team from the ground up, including defining organizational structure, hiring key talent, and establishing scalable processes and infrastructure.
• 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 a comparable electronic quality management system.

Responsibilities

• Define and execute regulatory strategies for neurotechnology and Class III implantable brain-computer interface products to support approval and commercialization.
• Assess current capabilities and strengthen quality 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 in study planning and execution.
• Align clinical evidence with regulatory approval pathways by working with Clinical Affairs, scientific advisors, and clinical investigators on study designs, endpoints, and evidence.
• Partner with Engineering, R&D, Clinical Affairs, and Operations to support products with clear evidence, sound risk decisions, and regulatory readiness.
• Guide complex product pathway, development tradeoff, and regulatory interaction decisions involving the FDA, global regulators, and Notified Bodies.
• Build and empower the QA/RA team by defining its organizational structure, hiring key talent, and establishing clear ownership.
• Translate quality and regulatory priorities into actionable plans that advance near-term milestones and long-term commercialization.

What This Job Offers

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