Senior Director of Regulatory

About Paradromics

Brain-related illness is one of the last great frontiers in medicine, not because the brain is unknowable, but because it has been inaccessible. Paradromics is building a brain-computer interface (BCI) platform that records brain activity at the highest possible resolution: the individual neuron. AI algorithms then decode this massive amount of brain-data, enabling seamless translation of thought into treatments.

Our first clinical application, the Connexus® BCI, will help people who are unable to speak, due to ALS, spinal cord injuries and stroke, to communicate independently through digital devices. However, the capabilities of our BCI platform go far beyond our first application. With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable mental illness.

As we transition into clinical operations and prepare for scale, we’re building a team that blends the urgency and creativity of a tech company with the rigor of a medical device firm. That means hiring people who thrive in fast-moving, high-trust environments—and who want to play a real role in shaping the future of neurotechnology.

The Role

Regulatory

This role will be responsible for the development of regulatory strategies and interpretation of applicable guidance documents and standards related to active implantable medical devices, neural implants, and brain-computer interfaces.  The primary focus is related to US FDA regulations and directly supporting the launch of clinical studies in the US, with additional focus on international markets and opportunities to conduct investigational device research in other areas.  The role will prepare FDA submissions and interact directly with FDA in support of Q-Sub, IDE, and PMA filings.  This role will function as a core team member across the development pipeline, and act as the regulatory resource for strategy, design control requirements, design and test strategy, and documentation review of design control deliverables.  This role will also be responsible for supporting the regulatory requirements of medical device software (for both implanted devices and external systems) and supporting the software development teams and software life cycle processes.  This role will work cross-functionally and collaborate closely with Quality, Engineering, Software Development, and the Clinical teams.  

This position is instrumental in supporting the company’s continued growth and future success, and requires an individual with a “can-do,” self-starter attitude who is excited about working collaboratively and diving into hands-on, detailed work in an early-stage medical device company.  This individual must be able to step back to view the bigger picture and understand where we are as a company to set priorities, strategy, and direction. 

Responsibilities include: 

• Lead the development and implementation of regulatory strategies including interpretation of applicable guidance documents and standards related to active implantable medical devices, neural implants, and brain-computer interfaces.   
• Address software and cybersecurity requirements into regulatory strategies and the related design and development plans, working closely with the Quality and Software Development teams during the planning and execution phases.  
• Function as a core team member on both software and hardware components to support the design control process, test planning/execution, and documentation review.
• Prepare and submit filings to the US FDA including Q-Subs, IDE, PMA, and other associated FDA interactions.  This role will lead the strategy and execution of FDA meetings and communications.
• Provide regulatory input and guidance on clinical use and clinical trial strategies.  
• Develop regulatory strategy and plans for clinical research and product approvals outside the US.
• Creation of SOPs, work instructions, and other regulatory affairs quality system elements.
• Effectively communicate regulatory requirements and strategies across the organization, from the core project team level to senior management.
• Conduct review of marketing and labeling materials
• Provide the regulatory perspective to clinical research plans and product development activities, including future expansion of clinical programs and next gen product offerings.
• Manage internal regulatory affairs training needs.
• Manage and grow the regulatory team.

Required Qualifications

• Bachelor’s degree in an Engineering, Science, or technical field.
• 7 years of experience in medical devices.
• Experience with medical device quality standards and regulations relating to active implantable devices and medical device software.  Recent experiences and real-time knowledge of FDA guidance and other applicable standards is highly desired.
• Experience as a core team member with hands-on responsibilities developing and implementing regulatory strategies.
• Experience engaging directly with FDA and other regulatory entities is highly desired.
• Successful history creating FDA submissions and managing the FDA review process with substantial experience interacting directly with FDA.  Software and cybersecurity FDA submission experiences are highly desired.
• Successful history developing and executing regulatory strategies outside the US.
• The desire to develop creative solutions to complex problems that meet regulatory requirements and business needs, while sharing knowledge and building consensus amongst stakeholders.  
• The desire to thrive in a team environment with a diverse group of people, where individual contributions are highly valued.
• The desire for continuous learning and improvement.
• Excellent communication skills both orally and in written form with a desire for in-person communication.  This includes experience leading meetings, projects, and presentations to small and large audiences.
• Excellent organizational skills and the ability to manage competing priorities and plan accordingly.  
• Ability to ensure strict confidentiality both internally and externally.
• Proficient skills with Microsoft Office Suite, Google G-Suite, and other PC based systems.

Preferred Qualifications

• Advanced degree(s) in Engineering, Science, or another related field.
• Experience working directly in the brain-computer interface space or deep brain stimulation.
• Experience with active electronic medical devices containing software.

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.