Viz.ai
Viz.ai improves access to life-saving treatments.
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Regulatory Affairs Specialist at Viz.ai

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Regulatory Affairs Specialist

About Viz.ai

Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with Threshold Ventures, CRV, and Google Ventures.

As a Regulatory Affairs Specialist you will:

  • Prepare US and international regulatory submissions and registrations in strategic markets by liaising with our partners and leveraging internal and external resources.
  • Project plan US and international regulatory submissions and or registrations including identifying key stakeholders, deliverables, milestones and dependencies to ensure timely project completion.
  • 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.
  • Serve as the representative from Regulatory Affairs in the review and approval of marketing, promotional material, and other device labeling.
  • 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 changes and documenting memorandums to file (MTF).
  • Perform post-market assessments based on field data to ensure continued product performance in the field.
  • Review and assess technical documentation and testing protocols to ensure compliance with special controls and other regulatory requirements.
  • Assess and evaluate labeling changes to user manuals, instructions, and training materials.
  • Review technical documentation to ensure that requirements and other specifications include relevant details for compliance.
  • Review design history files, device master records, and device history records for compliance with company processes and regulatory requirements.
  • Contribute towards improving company processes and procedures while continuing to ensure compliance with applicable regulations and relevant standards.
  • Maintain product and facility registrations with FDA and applicable regulatory bodies. 

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.
  • Demonstrated understanding of software concepts.
  • Availability to work hours that accommodate foreign time-zones.
  • Flexibility to travel occasionally (less than 25% of the time).

 

 Viz offers competitive benefits, including medical, dental, vision, 401k, generous vacation, and other great benefits to full-time employees.   

Viz.ai is an Equal Opportunity Employer and considers applicants for employment without regard to race, color, religion, sex, orientation, national origin, age, disability, genetics or any other basis forbidden under federal, state, or local law. If you’re applying for a position in San Francisco, review the San Francisco Fair Chance Ordinance guidelines applicable in your area.


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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
    • KotlinLanguages
    • PythonLanguages
    • SwiftLanguages
    • ReactLibraries
    • CircleCIFrameworks
    • AWS (Amazon Web Services)Frameworks
    • PostgreSQLDatabases
    • RedisDatabases
    • MixpanelAnalytics
    • TableauAnalytics
    • FigmaDesign
    • InVisionDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • Google SlidesManagement
    • JIRAManagement
    • Monday.comManagement
    • DriftCRM
    • LinkedIn SalesNavigatorCRM
    • OutreachCRM
    • SalesforceCRM
    • Salesforce CPQCRM
    • Salesforce PardotCRM
    • PardotEmail
    • ZoomInfoLead Gen
    • PardotLead Gen
    • LinkedInLead Gen
    • Google AdsLead Gen
    • Microsoft Advertising (Bing)Lead Gen
    • WhatsAppLead Gen
    • Definitive HealthcareLead Gen
    • TwitterLead Gen

What are Viz.ai Perks + Benefits

Culture
Friends outside of work
Intracompany committees
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Unconscious bias training
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Monthly wellness days
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Company sponsored family events
Vacation & Time Off Benefits
Unlimited Vacation Policy
Generous PTO
Paid Holidays
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Happy Hours
Parking
Home Office Stipend for Remote Employees
Professional Development Benefits
Job Training & Conferences
Cross functional training encouraged
Promote from within
Continuing Education stipend

Jobs at Viz.ai
22

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Finance
Data + Analytics
Design + UX
HR + Recruiting
Marketing
Operations
Product
Project Mgmt
Sales
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Senior Projet Manager

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Senior Project Manager About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner

Project Manager

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About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with

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About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with

Senior Financial Analyst

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About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with

Senior Director, Marketing Communications and Brand

Viz.ai
Remote
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Senior Director, Marketing Communications and Brand  About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight

Regulatory Affairs Specialist

Viz.ai
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2 weeks ago
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Regulatory Affairs Specialist About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks,

Regional Sales Manager - Ohio Valley Region

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Regional Sales Manager - NorthWest

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About Viz.ai: Viz.ai is a leader in applied artificial intelligence in healthcare. We are on a mission to fundamentally improve how healthcare is delivered in the world, through intelligent software that promises to reduce time to treatment and improve access to care. Viz.ai’s flagship product leverages advanced deep learning to communicate time-sensitive information about stroke patients straight to a specialist who can intervene and treat. We

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Product Marketing Manager - Life Sciences (Device)

Viz.ai
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Product Marketing Manager - Life Sciences (Device) About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight

Product Marketing Manager - Cardiology

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Product Marketing Manager - Cardiology About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners.

Global Life Science Partnership Executive

Viz.ai
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Global Life Science Partnership Executive About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners.

Director, Solutions Consulting

Viz.ai
Remote
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Director, Solutions Consulting About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks,

Customer Success Manager (Southeast)

Viz.ai
Remote
2 weeks ago
+31
Candidates must be located within one hour of a Tier I airport. About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners,

Customer Success Manager (Mid-Atlantic)

Viz.ai
Remote
2 weeks ago
+31
Candidates must be located within one hour of a Tier I airport. About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners,

Customer Success Associate (Texas)

Viz.ai
Remote
2 weeks ago
+31
Candidates must be located within one hour of a Tier I airport About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners,

Customer Success Associate

Viz.ai
Remote
2 weeks ago
+31
Candidates must be located within one hour of a Tier I airport About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners,

Customer Success Analyst

Viz.ai
Remote
2 weeks ago
About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage. Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with

Business Operations Analyst

Viz.ai
Remote
2 weeks ago
About Viz.ai Viz.ai was the first company to create AI-powered suspected stroke detection and triage.  Viz.ai was honored with numerous awards, including being among Fast Company's Most Innovative Companies in 2019. Viz.ai is currently in more than 850 hospitals. Viz.ai has raised $150M year to date and is funded by top-tier Silicon Valley investors, including Scale Venture Partners, Insight Partners. Greenoaks, Kleiner Perkins, along with