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Position Summary

Senior Analyst – Regulatory Affairs is responsible for regulatory activities related to 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.

Job Responsibilities

• Work closely with cross-functional team members to ensure that products are developed, manufactured and distributed in compliance with applicable regional regulations.

• In collaboration with cross-functional team members, compile, prepare, review and make high-quality 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.

• Review changes in products, product specifications, and manufacturing processes to assess the regulatory implications of the change.

• Ensure 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 and for addressing audit findings.

• Engage with, negotiate and manage relationships with regulatory authorities

• Provide regulatory guidance to support compliance activities associated with the Quality Management System to fulfill international and domestic policies and regulations, including lifecycle management and design control requirements.

• Provide regulatory guidance/input on procedures and work instructions, including regulatory and other functions as needed, while applying appropriate regulatory standards and guidance documents.

• Monitor and share information on the evolving regulatory environment/landscape.

• Interpret new regulations for cross-functional team understanding.

• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies or biopharma partners.

Required Qualifications

• Bachelor’s degree (B.S or B.A) in science-related area of study.

• 5+ years of experience in a regulated environment, preferably moderate to high-risk devices like US Class II or Class III, in a regulatory or quality function.

• Experience with domestic and international medical device/in-vitro diagnostic regulations, including standards and guidance documents like 21 CFR Parts 801, 803, 807, 812, 820; ISO 13485:2016, IVDR CE Marking.

• An understanding of document control requirements, design control, and experience working in a regulated environment.

• Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project.

Preferred Qualifications

• Experience reading and writing documentation in a scientific setting.

• Experience in writing Health Authority regulatory submissions.

• Ability to work independently, taking ownership for the management of processes, projects, and timelines.

• Effective time management & project planning skills.

• Adaptable to changing regulatory landscapes and business needs.

• Ability to manage multiple programs/tasks.

Physical Demands

• 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.

Other

• Job may require after-hours response or some work over the weekends/holidays to address emergency health authority submission related issues.

• Periodically scheduled on-call may require after-hours response for technical emergencies not explicitly related to assigned job responsibilities.

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.