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 Regulatory Affairs Analyst is responsible for maintaining regulatory compliance to all applicable regulatory requirements.

Job Responsibilities

• The Regulatory Affairs Specialist will ensure regulatory compliance by completing thorough assessments and the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies.

• Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier and Technical File.

• Apply regulatory standards, guidance documents, and industry expectations to product strategies and submissions. Guides others in the organization who are working on similar products.

• Identify requirements and potential obstacles for new product development teams.

• Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, communication and collaboration internally and external, submission, registration, obtaining approval/clearance, documentation, post marketing compliance.

• Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.

• Possess and apply a broad and advanced knowledge, skills/abilities and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures.

• Author and update SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiency.

• Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.

• Lead negotiations and interactions with regulatory authorities during the development and review process to ensure submission approval/clearance.

• Advise personnel on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications or marketing applications.

• Provide regulatory input to product lifecycle planning.

• Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

• Review of advertising and promotional items.

• Assist in SOP development and review.

Required Qualifications

• A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.

• A minimum of 3 years of experience in an FDA regulated industry.

• A minimum of 3 years of Regulatory Affairs experience.

• Regulatory Experience required (e.g., 21 CFR Part 820, ISO 13485, MDSAP).

Preferred Qualifications

• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.

• Ability to sit for extended periods of time.

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

Other

• 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 of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.