About Viz.ai

Viz.ai is the pioneer in the use of AI algorithms and machine learning to increase the speed of diagnosis and care, covering more than 220 million lives across 1,300+ hospitals and health systems in the U.S. and Europe. The AI-powered Viz Platform is an intelligent care coordination solution that identifies more patients with a particular disease, informs critical decisions at the point of care, and optimizes care pathways and helps improve outcomes. Backed by real-world clinical evidence, the Viz Platform delivers significant value to patients, providers, and pharmaceutical and medical device companies. For more information visitviz.ai.

You will:

• 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.

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).

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.

As part of our commitment to health and safety, we require Viz.ai employees to be fully vaccinated before any in-person meetings unless you are exempt.

Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all US locations. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Salary Range: $106,000  - $118,000 

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