Location: SF Bay Area, USA
Position Type: Full-Time
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
- Remote work with availability in the European time zone and business trips