Regulatory Affairs Analyst; Hybrid

Overview

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.

Regulatory Affairs Analyst is responsible for regulatory activities related to medical devices/ in vitro diagnostic products, including supporting regulatory compliance activities for US and international regions. This position will have a variety of responsibilities, including change impact assessments and supporting tasks related to US and international regulatory applications.

• Provide support for product development, manufacturing and distribution in compliance with applicable regional regulations.
• Support compilation, preparation, review and submissions of Health Authority regulatory applications in a timely manner. This can include US applications such as IDE, 510(k) s and PMA supplements, as well as international submissions like technical files for CE marking and Clinical Performance Studies. Support review of changes in products, product specifications, and manufacturing processes to assess the regulatory implications of the change.
• Support continued regulatory compliance throughout product’s life cycle.
• Provide support, as needed, for Health Authority Audits like FDA Inspections, Pre-Approval Inspections, BIMO or European Notified Body inspections.
• Support regulatory compliance with relevant regulations and effectively manage timely submissions to the appropriate regulatory authorities.
• Support compliance activities associated with the Quality Management System to fulfill international and domestic policies and regulations, including lifecycle management and design control requirements.
• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.

• Bachelor’s degree in science-related area of study.
• 3+ years’ experience in a regulated environment, preferably moderate to high-risk devices (US Class II or Class III), in a regulatory or quality function.
• Knowledge of domestic and international medical devices, in-vitro diagnostic regulations, or pharmaceutical including standards and guidance documents.
• An understanding of document control requirements, design control, and experience working in a regulated environment.
• 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.

• Experience reading and writing documentation in a scientific setting.
• Experience in writing Health Authority regulatory submissions.

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit/stand for extended periods of time while using a computer.

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

• This position requires periodic travel and some evenings, weekends and/or Holidays.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment…