Full-Time

Regulatory Affairs Specialist

Posted on 3/24/2023

Viz.ai

Viz.ai

201-500 employees

AI-driven care coordination platform for hospitals

AI & Machine Learning

Compensation Overview

$106,000 - $118,000

Mid, Senior

Remote + 1 more

Required Skills
R
Requirements
  • Bachelor's degree in a scientific discipline or related technical field
  • Minimum of 5+ years of medical device regulatory experience or an advanced degree, with a focus on regulatory affairs and 2 years of medical device experience
  • Working knowledge of the Quality System Regulation 21 C.F.R. 820, ISO:13485:2016 and international regulations for medical devices (including but not limited to: EU, Canada, Brazil, Australia, and Japan)
  • Experience modifying existing projects and device files to conform to new and changing standards and regulations
  • Experience working with devices that incorporate software or experience with software as a medical device (SaMD) preferred
  • Availability to work hours that accommodate foreign time-zones and flexibility to travel occasionally (less than 25% of the time)
Responsibilities
  • Prepare US and international regulatory submissions and registrations in strategic markets by liaising with our partners and leveraging internal and external resources
  • Perform regulatory assessment of device classification and propose regulatory pathways for market access in the US and Internationally
  • Manage and maintain regulatory documents for submissions including correspondence with regulatory agencies worldwide
  • Participate in Risk Management activities as part of the Software Development Lifecycle (SDLC) and conduct risk assessments for device changes
  • Performing regulatory assessments for design and labeling changes, and documenting memorandums to file (MTF)
  • Review and assess technical documentation and testing protocols to ensure compliance with special controls and other regulatory requirements

Viz.ai harnesses the power of artificial intelligence to transform patient care in thousands of hospitals across the U.S. and Europe. By utilizing advanced AI algorithms for rapid interpretation of medical imaging, this company significantly accelerates the diagnostic and treatment processes, enhancing patient outcomes. The collaborative nature of Viz.ai’s platform signifies not only a technical advancement but also a step forward in fostering cohesive medical teamwork, making it an exemplary workplace for those passionate about leveraging technology to improve healthcare.

Company Stage

Series D

Total Funding

$291.6M

Headquarters

San Francisco, California

Founded

2016

Growth & Insights
Headcount

6 month growth

-7%

1 year growth

-5%

2 year growth

9%

Benefits

Health, dental, & vision insurance

401K retirement plan

Generous vacation time

Paid parental leave

Monthly wellness days

Professional development stipend

INACTIVE