VP, Regulatory Affairs & Quality Assurance
Blackrock Neurotech
Summary
The Vice President, Regulatory Affairs & Quality Assurance will provide strategic and operational leadership across Blackrock Neurotech's Regulatory Affairs and Quality Assurance functions, guiding regulatory strategy and quality systems that support development, clinical advancement, regulatory approval, and commercialization of next-generation neurotechnology and implantable brain-computer interface products.
Job description
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, guiding regulatory strategy and quality systems that support development, clinical advancement, regulatory approval, and commercialization of next-generation neurotechnology and implantable brain-computer interface products.
What You'll Do
- Lead the path to approval and commercialization by defining and executing regulatory strategies for neurotechnology and Class III implantable BCI products
- Build the quality foundation for scale by assessing current capabilities and strengthening systems and processes supporting product development, clinical readiness, and reliable performance
- Provide executive oversight of Clinical Affairs by guiding clinical strategy, priorities, budgets, and resources
- Align clinical evidence with the path to approval by partnering with Clinical Affairs, scientific advisors, and clinical investigators
- 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 and interactions with FDA, global regulators, and Notified Bodies
- Build and empower a capable QA/RA team by defining organizational structure, hiring key talent, and establishing clear ownership
- Shape executive decisions and drive execution by translating quality and regulatory priorities into actionable plans
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
- 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
- Demonstrated understanding of medical device clinical development and investigations, including study design, endpoints, evidence generation, and clinical study requirements
- Demonstrated experience building and leading a team from the ground up
- Experience strengthening or restructuring functions in a small or growing medical device organization
- 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
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
- Demonstrated experience taking Class III implantable medical devices through regulatory approval and commercialization
- Experience leading FDA regulatory interactions and submissions for implantable devices, including IDE and PMA programs
- Working with international regulators and Notified Bodies
- Strong working knowledge of ISO 13485, ISO 14971, FDA quality system requirements, and EU MDR
- Demonstrated understanding of medical device clinical development and investigations
- Demonstrated experience building and leading a team from the ground up
- Experience strengthening or restructuring functions in a small or growing medical device organization
- Ability to operate strategically while remaining close to the work
- 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
Company overview
Blackrock Neurotech is a pioneering medical device company at the forefront of brain-computer interface (BCI) technology development. Founded in 2008 and headquartered in Salt Lake City, Utah, the company specializes in creating implantable neural interface systems designed to restore function and independence to individuals suffering from neurological disorders. As the world leader in BCI technology, Blackrock Neurotech has developed the most sophisticated and long-tested human BCI system, with its pioneering neuroscience tools empowering innovation across more than 500 global institutional partners. The company's core technology platform utilizes microelectrode arrays implanted in the brain to read and decode neural signals, enabling patients with conditions such as paralysis, ALS, Parkinson's disease, epilepsy, and brain trauma to regain communication, mobility, and sensory functions. Their flagship product, MoveAgain, received FDA Breakthrough Device Designation in 2021 and represents the first commercial BCI system expected to transform patient care. With decades of cumulative patient experience totaling over 30,000 days of BCI usage, Blackrock Neurotech continues to push the boundaries of neurotechnology to help people walk, talk, see, hear, and feel again.