Regulatory and Clinical Trials Lead

Subsense Inc.; Palo Alto (CA); Remote; USD 120,000 - 160,000; Full time

Job summary

Subsense Inc. is seeking a Regulatory and Clinical Trials Lead to shape the regulatory strategy for innovative brain-computer interface technologies. This mid-senior level role involves overseeing regulatory compliance, managing clinical trials, and leading a team in a dynamic startup environment focused on neurotechnology.

Benefits

Competitive salary and benefits package

Opportunity for professional development

Collaborative and inclusive culture

Qualifications

• 6+ years of relevant experience in medical devices.
• Willingness to take on high risk, high reward challenges.

Responsibilities

• Oversee regulatory department and establish strategy.
• Work with interdisciplinary teams to build new BCI technology.
• Collaborate to establish medical device clinical trials.

Skills

Expertise in FDA regulations

Expertise in EU regulations

Experience designing clinical trials

Collaboration with regulatory agencies

Management experience

Fluency in English

Education

Advanced degree in biomedical engineering

Job description

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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

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

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