Manager - Regulatory Affairs (Remote)
Caris Life Sciences
4 hours ago
Remote
United States
Corporate Functions
Position Summary
- Manager, Regulatory Affairs responsible for regulatory activities related to in vitro diagnostic (IVD) projects and applicable submissions.
Job Responsibilities
- Serve as RA representative on project core teams, providing regulatory guidance and RA strategies.
- Review product, specification, and manufacturing changes to assess regulatory implications.
- Prepare regulatory documents for market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, and 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, Pre-Approval Inspections, and European Notified Body inspections (as needed).
- Guide partners and junior regulatory staff on regulatory requirements, including risk indications and timing for approval planning.
- Ensure regulatory compliance and timely submissions to appropriate authorities.
- Support Quality Management System compliance activities.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device/IVD products.
- Knowledge of U.S. and European submission/registration requirements.
- Strong product development and design controls understanding; cross-functional partnership.
- Independent ownership of processes/projects/timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree; prior IVD experience.
- Deep knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience with U.S. FDA submissions; writing/maintaining CE technical files.
- Ability to mentor/lead.
Other / Employment Process
- Periodic travel and some evenings/weekends/holidays may be required.
- Pre-employment: criminal background check, drug screening, credit check (for some roles), and reference verification.
- Annual hiring range: $124,000–$152,000 (final offer may vary).
- Manager, Regulatory Affairs responsible for regulatory activities related to in vitro diagnostic (IVD) projects and applicable submissions.
Job Responsibilities
- Serve as RA representative on project core teams, providing regulatory guidance and RA strategies.
- Review product, specification, and manufacturing changes to assess regulatory implications.
- Prepare regulatory documents for market clearance/approval/continuance (e.g., 510(k)s, IDEs, supplements, and 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, Pre-Approval Inspections, and European Notified Body inspections (as needed).
- Guide partners and junior regulatory staff on regulatory requirements, including risk indications and timing for approval planning.
- Ensure regulatory compliance and timely submissions to appropriate authorities.
- Support Quality Management System compliance activities.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing/executing regulatory strategies for medical device/IVD products.
- Knowledge of U.S. and European submission/registration requirements.
- Strong product development and design controls understanding; cross-functional partnership.
- Independent ownership of processes/projects/timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree; prior IVD experience.
- Deep knowledge of IVD reagent chemistry, lab automation, and software components.
- Experience with U.S. FDA submissions; writing/maintaining CE technical files.
- Ability to mentor/lead.
Other / Employment Process
- Periodic travel and some evenings/weekends/holidays may be required.
- Pre-employment: criminal background check, drug screening, credit check (for some roles), and reference verification.
- Annual hiring range: $124,000–$152,000 (final offer may vary).