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Quality Assurance & Regulatory Affairs Lead

Q Bio

Q Bio

Legal, Quality Assurance
San Carlos, CA, USA
Posted on Friday, April 12, 2024
Q Bio is building technology for the Physical of the Future that measures more, faster and cheaper about the human body, to enable proactive primary care for all. We're revolutionizing primary care with the first clinical digital twin platform, powered by breakthrough whole-body scanning technology, that highlights the most important changes in a person’s physiology for sharing with physicians and specialists anywhere in the world.
Join us!
Q Bio’s clinical digital twin platform, Gemini, is the first to capture and monitor comprehensive baseline patient health in a scalable virtual model. The Gemini Dashboard highlights the most important chemical and anatomical changes in an individual weighted by an individual’s lifestyle, genetic and medical history, that can be securely shared with physicians and specialists all over the world.
Gemini is powered by the fastest, most accessible, whole body scanner developed: the Mark I. Self-driving and optimized for primary care, the Mark I can complete a whole-body scan in 15 minutes or less in an open space, without radiation, breath holds, or claustrophobia. Patient comfort is maximized with the option to sit, stand, or lie down, and real-time telemetry is displayed throughout.
Why should you consider a career with Q Bio?
We dream big. Our team is aligned and excited about the opportunity to save lives and understand the human body like never before. We know how critical empowering and supportive leadership is, both to our excellence as a company, and for our team experience as a whole, and our leadership team will empower and support career growth. We’re a team of engineers, scientists, and operators who come from a diverse background of disciplines and experiences. We value teamwork, growth, determination and persistence, commitment to collaboration, and a reliance on staying nimble while keeping the big picture in mind.
We are looking for an experienced Regulatory Affairs & Quality Assurance Lead to oversee our Mark I whole-body scanner regulatory submission and maintain market authorisation for our Gemini digital twin platform for compliance and commercial viability. You will be an important member of our leadership and product team.

Responsibilities include:

  • Oversee all regulatory submissions for medical devices (both hardware and software) and partner with leadership on appropriate regulatory product roadmaps
  • Organize and coordinate scientific data, relevant documents, and prepare 510(k) submission of a Class 2 medical device
  • Present and communicate with relevant regulatory agencies and carry out any subsequent negotiations necessary to obtain or maintain marketing authorisation for products concerned
  • Collaborate with Engineering team and Technical Program Manager(s) for all proper documentation and provide guidance on appropriate processes
  • Manage and coordinate with external counsel, advisors, and relevant research agencies

Qualifications

  • Experience and prior success in leading 510(k) submissions
  • Detail-oriented and strong organizational skills
  • Ability to prioritize and stay focused in a dynamic environment
  • Excellent communication and team collaboration skills
  • Strong desire to learn new topics related to the assigned technologies
  • Willingness to be hands-on and be both player/coach
  • Independent and proactive driver in their field of expertise
In the San Francisco Bay Area, the standard pay range for this role is $160,000-$200,000 annualized. This pay range is for the San Francisco Bay Area and is not applicable to locations outside of this location or for remote roles. Actual amounts will vary depending on experience, performance, and work location. In addition to a competitive base salary, we offer significant equity and an employee-friendly stock option plan. Employees will also be eligible to participate in benefits plans available to other similarly situated employees subject to any eligibility requirements imposed by such plans.
Q Bio was founded in 2015 by serial entrepreneur Jeffrey Kaditz, Dr. Michael Snyder, Chair of Genetics and Director of Personalized Medicine at Stanford University, and Dr. Garry Choy, physician, radiologist, and former Chief Medical Information Officer at Mass General Hospital. Q Bio has raised over $80M from world class investors including Andreessen Horowitz, Kaiser Foundation Hospitals, Khosla Ventures, Founders Fund, SciFi VC, and many more.
Q Bio is an Equal Opportunity Employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.