Manager - Regulatory Affairs (Hybrid)

Caris Life Sciences•Tempe, AZ

1d•Hybrid

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 Manager - Regulatory Affairs is responsible for regulatory activities related to medical devices / in vitro diagnostic projects and applicable health authority submissions. This position will have a variety of responsibilities, including developing regulatory strategies, preparation of regulatory documents, reviewing for regulatory compliance and monitoring of new policies and guidance from various regulatory agencies.

Requirements

Bachelor’s degree in a science-related area of study.
8+ years hands-on submission experience including the development 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 processes, 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.
Effective time management & project planning skills.

Nice To Haves

Master’s degree in a science-related area of study.
Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, software components of IVD medical devices, and NGS.
Experience leading and/or supporting US FDA medical device submissions.
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.
Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510(k)s, IDEs, PMAs, supplements, as well as international submissions like technical files for CE marketing and Clinical Performance Studies.
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 Health Authority inspections, including but not limited to FDA inspections, Pre-Approval Inspections, BIMO 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 fulfil international and domestic policies and regulations.
Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.