Regulatory and Clinical Trials Lead Job at Subsense Inc., Palo Alto, CA

K09GR2E4Yktxb0o0MXFYOU5HNUM4V3FDdkE9PQ==
  • Subsense Inc.
  • Palo Alto, CA

Job Description

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

Job Tags

Full time, Remote job, Worldwide,

Similar Jobs

Aviata Health Group

Director of Patient Experience Job at Aviata Health Group

 ...Aviata Health Group is looking for a Aviata Health Group is looking for a Director of Patient Experience to join our family! Customer service role Monday - Friday from 11am-7pm. Before a resident arrives at our center, our Customer Service Concierge will ensure... 

Advantage Technical

Coordinate Measuring Machine Programmer Job at Advantage Technical

 ...CMM Programmer Pay Up To: $85,280 a year Shift: 8 am till 5pm Position Summary: The CMM Programmer is responsible for developing and maintaining Coordinate Measuring Machine (CMM) programs for both new and existing products using Calypso, PC-DMIS, or other... 

360 SMART LINGO

Hindi Consecutive Interpreter Job at 360 SMART LINGO

 ...Job Title: Hindi Remote Consecutive Interpreter - On-Demand Location: Remote Job Type: Independent Contractor Experience Level: Experienced A 360 Smart Lingo consecutive, over-the-phone interpreter and video Remote Interpreter plays a crucial role in facilitating... 

Isriel Ponzoli, P.A.

Associate Attorney Job at Isriel Ponzoli, P.A.

 ...needed for Miami / Brickell Area insurance defense litigation practice...  ...is a plus. If you want to work in a fast-paced and friendly...  ...ability to connect and work from home and reasonable billing targets...  ...package including medical and dental insurance, generous 401(k)... 

American Honda Finance Corporation

Credit Buyer Job at American Honda Finance Corporation

 ...form of both retail installment sales contracts and leases, depending on the product and the needs of the customer. The Credit Buyer is responsible for approving or denying credit applications, following purchase policy guidelines, and establishing and maintaining positive...