Manager - Regulatory Affairs (Remote)
Caris Life Sciences
June 25, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Position Summary
- Manager, Regulatory Affairs responsible for regulatory activities for in vitro diagnostic (IVD) projects and related submissions, including regulatory document preparation, compliance review, and monitoring new agency guidance.
Job Responsibilities
- Lead as RA representative on core project teams, providing regulatory guidance and RA strategies.
- Independently assess regulatory implications of changes to products, specifications, and manufacturing processes.
- Prepare 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, including regulatory strategy and pre-submissions.
- Provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and European Notified Body inspections as needed.
- Guide partners and junior regulatory staff on requirements, risk considerations, and approval timing.
- Ensure regulatory compliance and timely submissions to appropriate authorities.
- Support Quality Management System compliance activities.
Required Qualifications
- Bachelor’s degree in a science-related field.
- 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.
- Strong understanding of product development/design controls and ability to partner cross-functionally.
- Ability to work independently with ownership of processes, projects, and timelines.
- Proficient in MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related field.
- Prior IVD experience; in-depth knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience leading/supporting U.S. FDA submissions.
- Experience writing/maintaining CE Technical Files.
- Ability to mentor and lead others.
Other
- Periodic travel and some evenings/weekends/holidays may be required.
Annual Hiring Range
- $124,000–$152,000.
- Manager, Regulatory Affairs responsible for regulatory activities for in vitro diagnostic (IVD) projects and related submissions, including regulatory document preparation, compliance review, and monitoring new agency guidance.
Job Responsibilities
- Lead as RA representative on core project teams, providing regulatory guidance and RA strategies.
- Independently assess regulatory implications of changes to products, specifications, and manufacturing processes.
- Prepare 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, including regulatory strategy and pre-submissions.
- Provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and European Notified Body inspections as needed.
- Guide partners and junior regulatory staff on requirements, risk considerations, and approval timing.
- Ensure regulatory compliance and timely submissions to appropriate authorities.
- Support Quality Management System compliance activities.
Required Qualifications
- Bachelor’s degree in a science-related field.
- 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.
- Strong understanding of product development/design controls and ability to partner cross-functionally.
- Ability to work independently with ownership of processes, projects, and timelines.
- Proficient in MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related field.
- Prior IVD experience; in-depth knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience leading/supporting U.S. FDA submissions.
- Experience writing/maintaining CE Technical Files.
- Ability to mentor and lead others.
Other
- Periodic travel and some evenings/weekends/holidays may be required.
Annual Hiring Range
- $124,000–$152,000.