Regulatory and Clinical Trials Lead

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

Head of Research & Development — Healthcare Nanotechnology

Head of Research & Development — Healthcare Nanotech-nology

Location: Europe / USA

Position Type: Full-Time

Job Summary:
We are seeking a seasoned and visionary leader to manage our team as the Head of Research & Development. The successful candidate will possess deep knowledge and extensive experience in nanotechnology and healthcare and will be responsible for steering the R&D department. He will make executive technology decisions on behalf of the company, ensuring the successful development and delivery of groundbreaking healthcare nanotechnology products, managing the technology budget, and leading a team of well-known global experts. The candidate must have strategic thinking, effective communication, and management skills.

Key Responsibilities:

Lead and manage the R&D department, fostering a culture of innovation and excellence. Managing operational processes associated with the project technical team.
Forming a holistic, coordinated interdisciplinary technology cluster of the company.
Develop and implement R&D strategies aligned with the company’s vision and objectives — participation in business development for all products.
Oversee the design, development, and testing of nanotechnology-based brain-computer interfaces and healthcare products.
Collaborate with cross-functional teams to ensure product development meets market needs.
Identify and assess emerging trends, innovation, and opportunities in healthcare nanotechnology.
Manage expert teams in the field of nanomaterials, IT, and SoC.
Secure and manage resources, including budget, personnel, and equipment, to support R&D initiatives.
Establish and maintain partnerships with academic institutions, research organizations, and industry peers. Taking a part in managing the Science Advisory Board.
Ensure compliance with regulatory standards and ethical guidelines in all research and development activities.
Provide timely reporting to company management about work stages, opportunities and achievements, difficulties and risks.
Preparation for an investment round and direct participation in pitching, search and attraction.
Creation and management of the intellectual property.
Assist in the recruitment and development of research and development personnel.

Qualifications:

Master’s degree in Nanotechnology, Biomedical Engineering, or a related field (PhD is an advantage).
Minimum of 10 years of experience in nanotechnology research and development, focusing on healthcare applications.
Proven track record of leading R&D teams and projects in Biotech, Medtech, and Nanotech.
Deep understanding of nanoparticles, physics, chemistry, and materials science (IT will be an advantage).
Demonstrated ability to develop and commercialize innovative healthcare products, manage large budgets, and justify spending.
Strong understanding of regulatory requirements and ethical guidelines in healthcare research.
Excellent leadership, communication, and interpersonal skills. Flexibility and change management skills.
Ability to think strategically and globally, solve complex problems, set tasks independently, and desire to build a world leader in the specialized field.
Experience working with foreign laboratories and foreign experts.
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.