Synchron

👥 11-50💰 $75,000,000 Series C about 2 years agoComputerMedicalMarketingMedical DeviceInformation TechnologyManufacturing💼 Private Company
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Synchron is a clinical-stage medical device company pioneering minimally invasive brain-computer interfaces (BCIs). Our flagship product, the Synchron Switch™, received FDA Breakthrough Device Designation and is currently in human clinical trials, aiming to restore communication and control for individuals with paralysis. We leverage advanced technologies in neurotechnology, endovascular procedures, and wireless data transmission to achieve our goal. Our engineering team values collaboration and innovation, fostering a dynamic, multi-disciplinary environment with a strong focus on quality and regulatory compliance. We're making significant strides in a rapidly evolving field, impacting the lives of millions with upper limb impairment. Our unique approach eliminates the need for open brain surgery, reducing risks and improving patient outcomes. The company's recent oversubscribed Series C funding round signifies significant investor confidence in our technology and its potential to revolutionize the treatment of paralysis. Our commitment to a positive and supportive work environment is a key part of our success. We offer opportunities for remote work within the US and embrace a collaborative culture where everyone's contributions are valued. We're seeking talented individuals to help us achieve our mission: to create a first-in-class commercial BCI and significantly improve the quality of life for patients around the world. Synchron is a rapidly growing company with a strong leadership team and a proven track record of innovation. We offer competitive salaries and benefits and pride ourselves on a supportive, inclusive culture where you'll be part of a mission-driven team working at the forefront of medical technology.

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📍 USA

💸 125000 - 140000 USD per year

🔍 Clinical-stage endovascular brain computer interface

  • 6 years of experience in U.S. and global Class II or III medical device regulatory affairs.
  • Submissions experience in medical devices, SaMDs, AI/ML-enabled devices, and digital health software.
  • Experience in developing complex submissions with strong organization and attention to detail.
  • Ability to work independently and across functions with minimal supervision.
  • Knowledge of ISO 13485, design controls, IEC 60601, ISO 14708.
  • Understanding of quality, clinical, and regulatory processes.
  • Strong technical writing, negotiation, and communication skills.
  • Experience in supporting audits.

  • Participate in Product Development teams providing regulatory input.
  • Write and compile regulatory submissions such as IDEs, QSubmissions, PMAs.
  • Lead regulatory project management and drive submissions to approval.
  • Create necessary SOPs and materials for regulatory compliance.
  • Advise the team on regulatory requirements for submissions and post-market obligations.
  • Contribute expertise to improve workflows and submission processes.
  • Educate and train the team on regulatory and quality processes.
  • Manage multiple projects in a fast-paced environment.
  • Develop relationships with regulatory advisors.

Project ManagementProduct DevelopmentStrategyCommunication SkillsCollaborationNegotiationAttention to detailDocumentationComplianceCross-functional collaboration

Posted about 2 months ago
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