Full-Time

Senior Regulatory Affairs Specialist

Posted on 8/27/2024

Synchron

Synchron

51-200 employees

Develops brain-computer interface technology for patients

Biotechnology
Healthcare

Compensation Overview

$110k - $125kAnnually

Senior

Brooklyn, NY, USA

Category
Risk & Compliance
Legal & Compliance
Requirements
  • 4-6 years of experience in U.S. and global Class II or III medical device regulatory affairs (active implantable device is a plus)
  • Submissions experience in medical devices, SaMDs, AI/ML-enabled medical devices, deep learning-enabled devices, and digital health software.
  • Have experience in developing complex submissions. Strong organization and attention to detail.
  • Work independently and cross-functionally with minimal supervision.
  • Proven ability to prioritize, conduct, and manage time to meet project deadlines
  • Working knowledge of ISO 13485, design controls, IEC 60601, ISO 14708
  • Understands interaction of quality, clinical and regulatory processes
  • Strong technical writing skills
  • Good negotiation and written/oral communication skills
  • Has supported audits
Responsibilities
  • Provide regulatory strategy and guidance on medical device throughout the product development lifecycle, including clinical validation, analysis for stand-alone and clinical performance; AI/ML-enabled devices and SaMD products
  • Review and approve R&D, quality and clinical documentation for submission
  • Partner with cross functional teams to define scope and innovative regulatory strategy for design and development activities
  • Assist with product labeling and review for compliance
  • Keep abreast with FDA and international guidance documents and regulations
  • Contribute to developing policies, processes, and SOPs necessary to support regulatory compliance including identification of opportunities for improved efficiencies within processes
  • Actively participate in problem-solving discussions and recommend solutions
  • Partner with the cross-functional team to allow for streamlined workflows, timely and relevant submissions, and thoughtful and creative approaches for the BCI space
  • Experience with device software development
  • Ability to manage multiple projects and work in a fast-paced, changing environment

Synchron develops brain-computer interface (BCI) technology that enables individuals, particularly those with severe paralysis, to control digital devices using their thoughts. Their main product involves a minimally invasive endovascular procedure for implanting the BCI, which is similar to placing stents and avoids the need for open brain surgery. This approach makes the technology safer and more accessible for a wider range of patients. Unlike competitors, Synchron focuses on providing a solution that enhances patient autonomy and social connection through direct brain data access. The company's goal is to empower patients with neurological conditions by improving their quality of life through advanced medical technology.

Company Stage

Series C

Total Funding

$130.6M

Headquarters

New York City, New York

Founded

2016

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

3%

2 year growth

16%
Simplify Jobs

Simplify's Take

What believers are saying

  • Synchron's partnership with Amazon expands BCI functionality through device integration.
  • Generative AI integration in BCI offers intuitive communication for individuals with severe paralysis.
  • The minimally invasive BCI implantation broadens accessibility for patients with neurological conditions.

What critics are saying

  • Competition from companies like Blackrock Neurotech may impact Synchron's market share.
  • Data privacy concerns arise from integrating generative AI into Synchron's BCI platform.
  • Regulatory hurdles could delay Synchron's market entry and expansion for brain implants.

What makes Synchron unique

  • Synchron's BCI uses minimally invasive endovascular procedures, unlike traditional open-brain surgeries.
  • The integration of generative AI enhances communication for non-verbal individuals using Synchron's BCI.
  • Synchron's community-centered BCI registry fosters collaboration among patients, caregivers, and clinicians.

Help us improve and share your feedback! Did you find this helpful?

INACTIVE