Head of Quality and Regulatory

Remote /
Clinical & Regulatory/Compliance /
Full-time
Summary: Join VideaHealth as a key member working closely with the CEO and clinical & engineering leadership. You will play the central role in driving the company’s regulatory efforts in building safe AI-driven medical software devices that will eventually improve dental health of millions of people. 

About us: VideaHealth is a venture-backed startup developing artificial intelligence to automatically detect diseases in dental x-ray imaging. Spun out of MIT in 2018, our prior research has shown that dentists miss up to 50% of dental diseases. VideaHealth helps dentists detect these conditions and effectively communicate treatment recommendations to patients. Our product increases revenue for dentists and has the potential to reduce health risks for over 210 million patients every year in the US alone. In addition, we are helping dental insurance companies streamline their claims review process with AI. We have a strong core team and advisors, and we have raised over $6.5M in seed funding so far. Our investors include Pillar VC (invested in Path AI), Zetta Venture Partners (invested in Tractable), and angel investors like Frederic Kerrest (Co-founder of Okta), Avid Larizadeh Duggan (Former Google Ventures Partner), and Bradley Armstrong (Vice President at Slack). Our work has been featured at Techcrunch and theWall Street Journal. We have great momentum and are now looking for ambitious talent to join our team!

About the position: As a Head of Regulatory Affairs & Quality you will report directly to the CEO. You will take ownership cross-functionally and work with Videa’s Clinical, Engineering and Product teams to establish processes that ensure the creation of high-quality, data secure and safe AI-driven medical devices in line with regulations. 

Your key responsibilities include:

    • Lead a multi-disciplinary group and act as liaison with regulatory bodies (FDA) to complete successful regulatory submissions of AI-powered SaMD systems
    • Ensure documentation and technical content is in agreement with the regulations and guidances provided by the FDA
    • Provide regulatory guidance and compliance oversight of company-sponsored clinical studies and the Videa’s product development.
    • Manage, review and improve Videa’s quality management system.
    • Design, conduct and document training activities of Videa staff within the QMS
    • Understand privacy policies and regulations (e.g. HIPAA) to establish and control processes ensuring data security and patient privacy.
    • Identification, tracking and completion of regulatory milestones within a larger product timelineConduct internal audits and act as point of contact for external audits

Requirements

    • Bachelor degree with 4+ years of relevant experience in industry (RA, QA, building regulated medical devices)
    • In depth knowledge of US medical device regulations and quality management systems
    • Experience in writing standard operating procedures and documentation (e.g. clinical study/validation protocols, SRS) in line with existing regulations
    • Experience with HIPAA regulations and designing policies for data security / patient privacy
    • Analytical and strategic thinking with a focus on deadlines and budgets
    • Excellent written, verbal communication and strong presentation, collaboration skills

Preferred

    • Technical background (e.g. formal education in Engineering, Science related field)
    • Experience with software development and/or software testing
    • Experience designing clinical studies and IRB processes
    • Experience with medical imaging systems and handling data in the form of medical images or patient reports
    • Familiarity with statistical concepts to inform the design of clinical studies (e.g. study endpoints).
    • Ability to consolidate and analyse diverse data sources
    • Track record of scientific writing, e.g. published scientific articles
    • Proven track-record of successful FDA applications