Manager - Regulatory Affairs (Remote)
Caris Life Sciences
2 days ago
Remote friendly (Boston, MA)
United States
Corporate Functions
Position Summary
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic projects and applicable submissions, including preparation of regulatory documents, regulatory compliance review, and monitoring new guidance from regulatory agencies.
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, and CE technical files).
- Lead pharmaceutical partner interactions for new and sustaining projects (regulatory strategy and pre-submissions).
- Review and provide regulatory input on analytical and clinical study protocols.
- Support, as needed, FDA inspections, Pre-Approval Inspections, and European Notified Body Inspections.
- 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 appropriate authorities.
- Support Quality Management System compliance activities aligned to international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing and executing regulatory strategies for medical device and/or IVD products.
- Knowledge of U.S. and European product submission/registration requirements for medical devices/IVD products.
- Strong understanding of product development process and design controls; cross-functional partnership.
- Ability to work independently and own processes/projects/timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area.
- Prior experience with in vitro diagnostics.
- In-depth knowledge of IVD reagent chemistry, laboratory automation, and software components.
- Experience leading and/or 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
Conditions of Employment
- Complete pre-employment process including 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, including preparation of regulatory documents, regulatory compliance review, and monitoring new guidance from regulatory agencies.
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, and CE technical files).
- Lead pharmaceutical partner interactions for new and sustaining projects (regulatory strategy and pre-submissions).
- Review and provide regulatory input on analytical and clinical study protocols.
- Support, as needed, FDA inspections, Pre-Approval Inspections, and European Notified Body Inspections.
- 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 appropriate authorities.
- Support Quality Management System compliance activities aligned to international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 6+ years hands-on submission experience developing and executing regulatory strategies for medical device and/or IVD products.
- Knowledge of U.S. and European product submission/registration requirements for medical devices/IVD products.
- Strong understanding of product development process and design controls; cross-functional partnership.
- Ability to work independently and own processes/projects/timelines.
- Proficient with MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area.
- Prior experience with in vitro diagnostics.
- In-depth knowledge of IVD reagent chemistry, laboratory automation, and software components.
- Experience leading and/or 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
Conditions of Employment
- Complete pre-employment process including criminal background check, drug screening, credit check (for certain positions), and reference verification.