Manager - Regulatory Affairs (Remote)
Caris Life Sciences
3 days ago
Remote friendly (Irving, TX)
United States
Corporate Functions
Position Summary
Manager - Regulatory Affairs responsible for regulatory activities for in vitro diagnostic projects and applicable submissions, including preparation of regulatory documents, regulatory compliance review, and monitoring new guidance.
Job Responsibilities
- Serve as RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently assess regulatory implications of changes to products, specifications, and manufacturing processes.
- Prepare documents for new product market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, CE technical files).
- Lead regulatory 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, Pre-Approval Inspections, and European Notified Body inspections as needed.
- Guide 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 field.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD products.
- Knowledge of U.S. and European submission/registration requirements for medical devices/IVDs.
- Strong understanding of product development/design controls; ability to partner cross-functionally.
- Ability to work independently and own 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 with U.S. FDA submissions and/or CE Technical Files.
- Ability to mentor/lead others.
Annual Hiring Range
- $124,000.00 - $152,000.00
Conditions of Employment
- Successful completion of pre-employment process (background check, drug screening, credit check if applicable, and reference verification).
Manager - Regulatory Affairs responsible for regulatory activities for in vitro diagnostic projects and applicable submissions, including preparation of regulatory documents, regulatory compliance review, and monitoring new guidance.
Job Responsibilities
- Serve as RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently assess regulatory implications of changes to products, specifications, and manufacturing processes.
- Prepare documents for new product market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, CE technical files).
- Lead regulatory 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, Pre-Approval Inspections, and European Notified Body inspections as needed.
- Guide 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 field.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD products.
- Knowledge of U.S. and European submission/registration requirements for medical devices/IVDs.
- Strong understanding of product development/design controls; ability to partner cross-functionally.
- Ability to work independently and own 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 with U.S. FDA submissions and/or CE Technical Files.
- Ability to mentor/lead others.
Annual Hiring Range
- $124,000.00 - $152,000.00
Conditions of Employment
- Successful completion of pre-employment process (background check, drug screening, credit check if applicable, and reference verification).