Are you ready to shape the future of neurotechnology and transform lives? Our client, a cutting-edge startup, is pushing the boundaries in the treatment of neurological disorders with their advanced brain-computer interface (BCI) technology.

As the VP of Regulatory Affairs, you’ll take the lead in navigating the complex regulatory landscape for this innovative medical device. You’ll work closely with the FDA to chart a path for our client’s next-generation non-invasive BCI system, designed to significantly improve mobility in patients with severe paralysis.

Responsibilities

• Spearhead regulatory strategy for our client’s novel AI-powered neural decoding algorithms
• Work closely with R&D, clinical, and quality teams to integrate regulatory requirements into the product development lifecycle, ensuring compliance at every stage
• Lead interactions with regulatory bodies worldwide, paving the way for global market access
• Stay ahead of the evolving regulatory landscape, interpreting new regulations, guidelines, and standards that may impact the company’s products
• Lead regulatory submissions and negotiations for market approvals in key international markets, including US, Europe, UK and Asia
• Build and lead a high-performing regulatory affairs team, providing mentorship and professional development opportunities
• Represent the company in regulatory meetings, conferences, and industry groups, establishing the company as a thought leader in neurotechnology

Requirements

• 10+ years of experience in regulatory affairs within the medical device industry, with a focus on complex, innovative technologies
• Advanced degree in Regulatory Affairs, Biomedical Engineering, Neuroscience, or a related field
• Proven track record of successful interactions with the FDA, particularly in the approval of novel medical devices
• Experience in global regulatory submissions and approvals, including FDA, CE Marking and other international certifications
• Familiarity with neurotechnology, BCI systems, or related fields such as AI in healthcare, neural interfaces, or implantable devices
• Strong leadership and team management skills, with a history of building and leading successful regulatory teams

Company benefits

• Full medical, dental, and vision insurance to support your well-being.
• Stock options to share in the company’s growth and success.
• Hybrid work model with the option to work remotely.
• Opportunities for continued learning, including conferences, workshops, and certifications.
• Ample vacation days, plus paid holidays and sick leave.

This role offers a unique opportunity to be at the forefront of technology that promises to redefine patient care in neurology. Join a passionate team backed by top-tier investors and help bring this life-changing innovation to those who need it most.

Interested in pushing the boundaries of neurotech? Apply now and be part of this exciting journey!