Director of Quality and Regulatory Affairs Los Angeles, California

Company: Tbwa Chiat/Day Inc
Location: Los Angeles
Posted on: February 1, 2025

Job Description:

Director of Quality and Regulatory AffairsOpen Position - Director of Quality and Regulatory AffairsHorizon Surgical Systems Inc.Horizon Surgical Systems Inc. is revolutionizing the world of surgical ophthalmology by developing a novel, AI driven, and imaging-guided surgical robotic system. Horizon Surgical Systems Inc. aims to expand access to care, provide superior capabilities to the human surgeon, and enhance patient outcomes. Microsurgery in general and Ophthalmology are subfields of surgery for which the surgical outcomes can be significantly improved by robotic systems to allow superior dexterity, precision, accuracy, and visualization beyond the human surgeon's own capabilities.We are seeking highly motivated, and intellectually inquisitive individuals looking to make a positive impact on healthcare via the development of robotic technology. The core values of Horizon Surgical Systems Inc. are:

• Commitment to Excellence: We aim to deliver superior patient outcomes and surgeon experiences
• Passion for Creativity and Innovation: We are driven by new ideas and aim to push the boundaries of what's possible
• Teamwork and Camaraderie: We achieve our best when we collaborate and work together
• Welcoming of Critical Opinion: We are enriched by constructive criticism and support the best ideas
• Personal Accountability: We honor our commitments and take responsibility for our actionsHorizon Surgical Systems Inc. offers:
  • An opportunity to build autonomous surgical robotic systems driven by image guidance and AI technology for the future of affordable, high-quality healthcare.
  • The opportunity to work alongside clinicians, engineers, and global leaders in cutting-edge AI, imaging, and robotics technology.
  • Competitive compensation and an excellent company-paid benefits package.As Director of Quality and Regulatory Affairs at Malibu-based Horizon Surgical Systems Inc., you will join a group revolutionizing the field of surgical ophthalmology and microsurgery. Your work will contribute to a paradigm shift focused on automating ophthalmological surgical procedures with robotic platforms.Job DescriptionWe are seeking a Director of Quality and Regulatory Affairs to lead our quality and regulatory efforts during the design and development phase of our medical device. This is a hands-on leadership role, essential to creating a compliant yet streamlined development and submission framework including quality management system (QMS), risk management process, design control documentation and regulatory submissions. The ideal candidate has an engineering mindset with strong expertise in design controls and risk management within regulatory framework. They excel at distilling critical details from ambiguity and using first principles when designing a process ensuring it's not cumbersome for non quality-regulatory members, and can support rapid iterations.Job Responsibilities and Description
    • Develop, implement, and maintain efficient, scalable quality system and design control process compliant with ISO 13485, FDA 21 CFR 820.30, ISO 14971, IEC 62304 and other relevant regulations.
    • Ensure that compliance with customer requirements, risk management, quality, and design control standards is demonstrated throughout design and development, with a particular emphasis on Hardware and Software in a Medical Device (SaMD), Cybersecurity, AI/ML and consumables.
    • Operationalize and maintain quality tools such as Quality System Software Green Light Guru (GLG) and PDM software.
    • Champion the design control process and help in developing design control documentation.
    • In collaboration with regulatory advisors, contribute to regulatory strategy, plan, and requirements for FDA Q-subs, IDE, Clinical Studies, and Product Approval submissions.
    • Lead the creation of technical, quality, and clinical documentation for clinical trial submissions and regulatory approvals (FDA, CE, etc.).
    • Generate and maintain risk management files supporting product development, including Risk Management Plans/Reports, Hazard Analyses, FMEAs, Design Trace Matrices.
    • Participate in decisions regarding the selection of materials, test methodologies, design reviews, and design changes.
    • Provide guidance and generate reports on topics involving statistical analysis, including testing sample size requirements, process capability analysis.
    • Hands-on, resourceful, flexible, and adaptable; no task is too big or too small.Qualifications
      • Bachelor's degree in Engineering, Life Sciences, or a related field - Advanced degree preferred.
      • 8+ years experience in quality and regulatory affairs with rigorous design control processes for medical devices with consumables, hardware, and software.
      • Experience with AI/ML and Cybersecurity regulatory requirements is a strong plus.
      • Experience in implementing and managing QMS and Design Controls in start-up environment.
      • Proven experience working across all stages of medical device development, from concept through design transfer to manufacturing.
      • Familiarity with agile software development processes is a plus.
      • Strong technical writing skills for creating regulatory documentation.
      • Excellent problem-solving, organizational, and leadership abilities.
      • Effective communication skills to collaborate across teams and provide regulatory guidance.Why Join Us?
        • Be a key contributor to groundbreaking surgical robotics technology.
        • Lead quality efforts in a dynamic, fast-paced startup environment.
        • Competitive compensation package with opportunities for equity.This is an exciting opportunity to join a high-tech startup that is poised to revolutionize surgical robotics in ophthalmology.If you're a quality assurance leader eager to shape the future of medical robotics, we want to hear from you!
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