Manager - Regulatory Affairs (Remote)
About The Position
At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins. Position Summary The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions. This position will have a variety of responsibilities to include preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new guidance from various regulatory agencies.
Requirements
- Bachelor’s degree in a science-related area of study.
- Minimum of 6 years hands-on submission experience including the developing and execution of regulatory strategies for medical device and/or IVD regulated products.
- Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products.
- Strong understanding of product development process, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies.
- Ability to work independently, taking ownership for the management of processes, projects, and timelines.
- Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.
Nice To Haves
- Master’s degree in a science-related area of study.
- Prior experience with in vitro diagnostics.
- Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Experience leading and/or supporting US FDA submissions.
- Experience in writing/maintaining CE Technical Files.
- Ability to mentor and lead others through challenging circumstances.
Responsibilities
- Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
- Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, IDEs, supplements, and technical files for CE marketing.
- Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions.
- Review and provide regulatory input on analytical and clinical study protocols.
- Provide support, as needed, for FDA inspections, Pre-Approval Inspections or European Notified Body Inspections.
- Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes.
- Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities.
- Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
