Regulatory and Clinical Trials Lead

Location: Bay Area, USA
On-site: Palo Alto
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Position Type: Full-Time
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Company Overview:
Subsense is a pioneering organization specializing in developing innovative nanotechnology solutions aimed at revolutionizing the field of noninvasive daily used Brain-Computer Interfaces and treating Neurodegenerative disease. We are committed to creating cutting-edge products that address complex health challenges and improve customer and patient outcomes.

Job Summary:
We’re seeking a visionary Regulatory and Clinical Trials Lead to pioneer our journey in brain-computer interface technology. This role offers a unique opportunity to shape the regulatory strategy of a cutting-edge medical device company. You’ll be at the forefront of innovation, working with a diverse team to navigate the complex landscape of global medical device regulations. If you’re passionate about bringing revolutionary technologies to market, have a knack for building and leading teams, and thrive in a fast-paced startup environment, we want you. Join us in transforming the future of neurotechnology and making a lasting impact on patient care.

Key Responsibilities:

• Overseeing regulatory department of the company, establishing a regulatory strategy and quality management system in collaboration with external consultants
• Working with a cross functional, interdisciplinary team to integrate hardware, software, nanoscience, data science, and regulatory to build new BCI technology
• Collaborating with internal teams and external collaborators to establish medical device clinical trials
• Interface and negotiate with US and worldwide regulatory agencies
• Qualify manufacturing partners and suppliers to assure quality standards are maintained
• Build, grow, and manage the regulatory teams
• Author regulatory procedures and submissions

Qualifications:

• Expertise in FDA, EU, and other worldwide medical device regulations
• Expertise in establishing and maintaining ISO 13485 and FDA compliant QMS systems for high complexity medical devices
• Experience designing and managing clinical trials for high complexity medical devices
• Experience with industrial scale up of wearable electronics and medical devices
• Experience working in early stage startup or other small companies
• Collaboration experience government agencies and regulatory consultants
• Management experience leading teams of 4+ people
• An advanced degree in biomedical engineering, biotechnology or a related field with 6+ years of relevant experience
• A willingness to take on high risk, high reward challenges
• Fluent in written and spoken English

What We Offer:

• Competitive salary and benefits package
• Opportunity to work in a dynamic and innovative environment
• Support for professional development and continuous learning
• Collaborative and inclusive company culture