Manager - Regulatory Affairs (Remote)
Caris Life Sciences
June 25, 2026
Remote friendly (Irving, TX)
United States
Corporate Functions
Position: Manager – Regulatory Affairs (IVD)
Job Responsibilities
- Lead regulatory affairs (RA) representation on project core teams, providing regulatory guidance and RA strategies.
- Review product/specification/manufacturing process changes and assess regulatory implications.
- Prepare regulatory documents for market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, CE Technical Files).
- Lead interactions with pharmaceutical partners on new and sustaining projects (regulatory strategy and pre-submissions).
- Provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and European Notified Body inspections as needed.
- Advise partners and junior RA staff on regulatory requirements, including risk indications and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to appropriate authorities.
- Support Quality Management System compliance activities (international/domestic policies and regulations).
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD regulated products.
- Knowledge of U.S. and European submission/registration requirements for medical devices/IVDs.
- Strong understanding of product development process and design controls; cross-functional partnership.
- Ability to work independently and own processes/projects/timelines.
- Proficiency with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area; prior IVD experience.
- In-depth knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience leading/supporting U.S. FDA submissions; writing/maintaining CE Technical Files.
- Ability to mentor/lead others.
Other
- Periodic travel; some evenings/weekends/holidays.
- Annual hiring range: $124,000–$152,000.
- Pre-employment process includes background check, drug screening, (credit check for some roles), and reference verification.
Job Responsibilities
- Lead regulatory affairs (RA) representation on project core teams, providing regulatory guidance and RA strategies.
- Review product/specification/manufacturing process changes and assess regulatory implications.
- Prepare regulatory documents for market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, CE Technical Files).
- Lead interactions with pharmaceutical partners on new and sustaining projects (regulatory strategy and pre-submissions).
- Provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and European Notified Body inspections as needed.
- Advise partners and junior RA staff on regulatory requirements, including risk indications and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to appropriate authorities.
- Support Quality Management System compliance activities (international/domestic policies and regulations).
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD regulated products.
- Knowledge of U.S. and European submission/registration requirements for medical devices/IVDs.
- Strong understanding of product development process and design controls; cross-functional partnership.
- Ability to work independently and own processes/projects/timelines.
- Proficiency with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area; prior IVD experience.
- In-depth knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience leading/supporting U.S. FDA submissions; writing/maintaining CE Technical Files.
- Ability to mentor/lead others.
Other
- Periodic travel; some evenings/weekends/holidays.
- Annual hiring range: $124,000–$152,000.
- Pre-employment process includes background check, drug screening, (credit check for some roles), and reference verification.