Manager - Regulatory Affairs (Remote)
Caris Life Sciences
June 25, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
Manager - Regulatory Affairs responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions, including preparation of regulatory documents, regulatory compliance reviews, and monitoring of new guidance from regulatory agencies.
Job Responsibilities:
- Lead as the RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently review product/product specification/manufacturing process changes to assess regulatory implications.
- Prepare documents for new product market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, and CE technical files).
- Lead pharmaceutical partner interactions for new and sustaining projects, including regulatory strategy and pre-submissions.
- Review and provide regulatory input on analytical and clinical study protocols.
- Support, as needed, FDA inspections and European Notified Body inspections.
- Guide pharmaceutical partners and junior regulatory staff on regulatory requirements, risk indications, and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities.
Required Qualifications:
- Bachelor’s degree in a science-related area.
- Minimum 6 years hands-on medical device/IVD submission experience, including developing and executing regulatory strategies.
- Knowledge of U.S. and European medical device/IVD submission and registration requirements.
- Strong understanding of product development/design controls; ability to cross-functionally partner.
- Ability to work independently and manage processes, projects, and timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications:
- Master’s degree in a science-related area.
- Prior in vitro diagnostics 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:
- $124,000.00 - $152,000.00
Manager - Regulatory Affairs responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions, including preparation of regulatory documents, regulatory compliance reviews, and monitoring of new guidance from regulatory agencies.
Job Responsibilities:
- Lead as the RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently review product/product specification/manufacturing process changes to assess regulatory implications.
- Prepare documents for new product market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, and CE technical files).
- Lead pharmaceutical partner interactions for new and sustaining projects, including regulatory strategy and pre-submissions.
- Review and provide regulatory input on analytical and clinical study protocols.
- Support, as needed, FDA inspections and European Notified Body inspections.
- Guide pharmaceutical partners and junior regulatory staff on regulatory requirements, risk indications, and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities.
Required Qualifications:
- Bachelor’s degree in a science-related area.
- Minimum 6 years hands-on medical device/IVD submission experience, including developing and executing regulatory strategies.
- Knowledge of U.S. and European medical device/IVD submission and registration requirements.
- Strong understanding of product development/design controls; ability to cross-functionally partner.
- Ability to work independently and manage processes, projects, and timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications:
- Master’s degree in a science-related area.
- Prior in vitro diagnostics 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:
- $124,000.00 - $152,000.00