Manager - Regulatory Affairs (Remote)
Caris Life Sciences
6 hours ago
Remote
United States
Corporate Functions
Position Summary
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions.
Job Responsibilities
- Lead as the RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications.
- Prepare documents for new product market clearance, approval, and continuance (e.g., 510(k)s, IDEs, supplements, CE technical files).
- Lead pharmaceutical partner interactions on new and sustaining projects, including regulatory strategy and pre-submissions.
- Review and provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and Pre-Approval Inspections, and European Notified Body Inspections as needed.
- Guide pharmaceutical partners and junior regulatory staff on regulatory requirements, including risk indications and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities with international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- Minimum 6 years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD regulated products.
- Knowledge of U.S. and European product submission/registration requirements for medical devices and/or IVDs.
- Strong understanding of product development process and design controls; ability to partner cross-functionally.
- Ability to work independently and take ownership of 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 understanding of IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Experience leading/supporting US FDA submissions.
- Experience writing/maintaining CE Technical Files.
- Ability to mentor and lead others.
Other / Conditions of Employment
- Periodic travel and some evenings, weekends, and/or holidays may be required.
- Pre-employment process includes criminal background check, drug screening, credit check (for certain positions), and reference verification.
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions.
Job Responsibilities
- Lead as the RA representative on project core teams, providing regulatory guidance and RA strategies.
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications.
- Prepare documents for new product market clearance, approval, and continuance (e.g., 510(k)s, IDEs, supplements, CE technical files).
- Lead pharmaceutical partner interactions on new and sustaining projects, including regulatory strategy and pre-submissions.
- Review and provide regulatory input on analytical and clinical study protocols.
- Support FDA inspections and Pre-Approval Inspections, and European Notified Body Inspections as needed.
- Guide pharmaceutical partners and junior regulatory staff on regulatory requirements, including risk indications and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities with international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- Minimum 6 years hands-on submission experience developing/executing regulatory strategies for medical device and/or IVD regulated products.
- Knowledge of U.S. and European product submission/registration requirements for medical devices and/or IVDs.
- Strong understanding of product development process and design controls; ability to partner cross-functionally.
- Ability to work independently and take ownership of 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 understanding of IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Experience leading/supporting US FDA submissions.
- Experience writing/maintaining CE Technical Files.
- Ability to mentor and lead others.
Other / Conditions of Employment
- Periodic travel and some evenings, weekends, and/or holidays may be required.
- Pre-employment process includes criminal background check, drug screening, credit check (for certain positions), and reference verification.