Simplify Logo

Full-Time

Senior Regulatory Affairs Specialist

Confirmed live in the last 24 hours

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
Required Skills
Communications
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 patients with neurological conditions that limit their ability to communicate or move. Unlike competitors, Synchron focuses on a less invasive method of BCI implantation, which can lead to quicker recovery times and a broader patient base. The company's goal is to enhance patient autonomy and social connection by providing them with the ability to interact with technology through thought, ultimately transforming their quality of life.

Company Stage

Series C

Total Funding

$135M

Headquarters

New York City, New York

Founded

2016

Growth & Insights
Headcount

6 month growth

8%

1 year growth

-5%

2 year growth

76%
Simplify Jobs

Simplify's Take

What believers are saying

  • The integration of OpenAI's generative AI into Synchron's BCI platform significantly enhances user autonomy and communication capabilities.
  • The launch of a patient registry fosters community collaboration, accelerating advancements in BCI technology and patient care.
  • Strategic acquisitions, such as the equity stake in ACQUANDAS, strengthen Synchron's technological innovation and supply chain.

What critics are saying

  • The highly specialized nature of Synchron's technology may limit its market size and scalability.
  • Dependence on successful clinical trials and regulatory approvals could delay commercialization and revenue generation.

What makes Synchron unique

  • Synchron's minimally invasive endovascular procedure for BCI implantation sets it apart from competitors requiring open brain surgery.
  • The integration of generative AI into their BCI platform enhances user communication, offering a unique value proposition in the BCI market.
  • Synchron's focus on patients with severe paralysis and neurological conditions allows it to address a highly specific and underserved market.