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.