Manager - Regulatory Affairs (Remote)
Caris Life Sciences
2 days ago
Remote friendly (United States)
United States
Corporate Functions
Position Summary
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic (IVD) projects and applicable submissions, including preparation of regulatory documents, compliance review, and monitoring of new guidance from regulatory agencies.
Job Responsibilities
- Lead as the regulatory affairs (RA) representative on project core teams with regulatory guidance and RA strategy.
- Independently review product, specification, and manufacturing process changes for regulatory implications.
- Prepare documents for new product market clearance/approval and continuance during product life cycle management (e.g., 510(k)s, IDEs, supplements, and 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 European Notified Body inspections as needed.
- Advise pharmaceutical partners and junior regulatory staff on regulatory requirements, including risk indicators and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities to meet international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 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.
- Strong understanding of product development and design controls; effective cross-functional partnering.
- Ability to work independently and manage processes, projects, and timelines.
- Proficient in MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area.
- In vitro diagnostics experience.
- Deep technical knowledge (IVD reagent chemistry, lab automation, software components).
- Experience with 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.
Conditions of Employment
- Complete pre-employment process including criminal background check, drug screening, credit check (as applicable), and reference verification.
The Manager - Regulatory Affairs is responsible for regulatory activities related to in vitro diagnostic (IVD) projects and applicable submissions, including preparation of regulatory documents, compliance review, and monitoring of new guidance from regulatory agencies.
Job Responsibilities
- Lead as the regulatory affairs (RA) representative on project core teams with regulatory guidance and RA strategy.
- Independently review product, specification, and manufacturing process changes for regulatory implications.
- Prepare documents for new product market clearance/approval and continuance during product life cycle management (e.g., 510(k)s, IDEs, supplements, and 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 European Notified Body inspections as needed.
- Advise pharmaceutical partners and junior regulatory staff on regulatory requirements, including risk indicators and approximate approval timing.
- Ensure regulatory compliance and manage timely submissions to regulatory authorities.
- Support Quality Management System compliance activities to meet international and domestic policies/regulations.
Required Qualifications
- Bachelor’s degree in a science-related area.
- 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.
- Strong understanding of product development and design controls; effective cross-functional partnering.
- Ability to work independently and manage processes, projects, and timelines.
- Proficient in MS Office (Word, PowerPoint, Excel, Visio, Outlook, Project).
Preferred Qualifications
- Master’s degree in a science-related area.
- In vitro diagnostics experience.
- Deep technical knowledge (IVD reagent chemistry, lab automation, software components).
- Experience with 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.
Conditions of Employment
- Complete pre-employment process including criminal background check, drug screening, credit check (as applicable), and reference verification.