PathAI
Get AI-powered advice on this job and more exclusive features.
Who We Are PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life‑saving therapies to patients more quickly. At PathAI, you’ll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.
Where You Fit As the Senior Product Quality Specialist, you will be a key member of PathAI’s Regulatory and Quality (RAQA) Team, ensuring compliance to the company’s Quality Management System and to pre‑ and post‑market regulations that pertain to PathAI’s RUO, IVD, and clinical products. You will be responsible for representing RAQA in company‑specific projects for diagnostic and clinical development services and will be involved in process improvement efforts, and participate in audits as needed. You will provide risk and regulatory assessments during design control and change control activities and participate in the development and submission of filings to regulatory agencies in the US, EMA, and other geographies. The ideal candidate brings knowledge in regulatory affairs and quality assurance, preferably in the context of AI‑driven diagnostic software, and thrives in a fast‑paced, high‑growth environment.
What You’ll Do
Quality system
Maintain and improve Product Development Process for the QMS aligned to FDA QSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and related standards; monitor new/updated regulations and flow them into the QMS.
Design controls & SaMD lifecycle
Guide teams through design inputs/outputs, V&V, risk management, usability, design transfer, and clinical/labeling impacts; review design documentation for compliance throughout the product life cycle.
Validate non-product software/tools (e.g., ETQ, JIRA) and document plans, protocols, and reports; contribute to risk management per ISO 14971.
Perform product risk and regulatory assessments for change orders.
Training & readiness
Monitor training, documentation, and release readiness across project teams to keep products and processes audit ready.
Regulatory strategy & submissions
Assist in the determination of registration strategy and author the technical file/design dossier content in partnership with Product, ML, Clinical, and Engineering.
Cross‑functional enablement
Serve as the day‑to‑day RA/QA partner to Product/ML/Engineering/Clinical Operations, resolving issues that affect submissions and compliance timelines for projects.
What You Bring
Bachelor’s degree in a relevant scientific/engineering field.
3+ years combined experience in RA/QA for medical devices, including SaMD/IEC 62304 environments: working knowledge of 21 CFR 820, ISO 13485, ISO 14971 and IVDR.
Demonstrated contributions to successful regulatory submissions and to design‑control‑driven development.
Strong analytical, documentation, and cross‑functional communication skills; able to work autonomously under tight timelines.
We Want To Hear From You At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we’re looking for.
Equal Opportunity Employer PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that’s all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don’t tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
Annual Pay Range $101,250 - $155,250
Not Overtime Eligible
Eligible for Equity
#J-18808-Ljbffr
Who We Are PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life‑saving therapies to patients more quickly. At PathAI, you’ll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact.
Where You Fit As the Senior Product Quality Specialist, you will be a key member of PathAI’s Regulatory and Quality (RAQA) Team, ensuring compliance to the company’s Quality Management System and to pre‑ and post‑market regulations that pertain to PathAI’s RUO, IVD, and clinical products. You will be responsible for representing RAQA in company‑specific projects for diagnostic and clinical development services and will be involved in process improvement efforts, and participate in audits as needed. You will provide risk and regulatory assessments during design control and change control activities and participate in the development and submission of filings to regulatory agencies in the US, EMA, and other geographies. The ideal candidate brings knowledge in regulatory affairs and quality assurance, preferably in the context of AI‑driven diagnostic software, and thrives in a fast‑paced, high‑growth environment.
What You’ll Do
Quality system
Maintain and improve Product Development Process for the QMS aligned to FDA QSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and related standards; monitor new/updated regulations and flow them into the QMS.
Design controls & SaMD lifecycle
Guide teams through design inputs/outputs, V&V, risk management, usability, design transfer, and clinical/labeling impacts; review design documentation for compliance throughout the product life cycle.
Validate non-product software/tools (e.g., ETQ, JIRA) and document plans, protocols, and reports; contribute to risk management per ISO 14971.
Perform product risk and regulatory assessments for change orders.
Training & readiness
Monitor training, documentation, and release readiness across project teams to keep products and processes audit ready.
Regulatory strategy & submissions
Assist in the determination of registration strategy and author the technical file/design dossier content in partnership with Product, ML, Clinical, and Engineering.
Cross‑functional enablement
Serve as the day‑to‑day RA/QA partner to Product/ML/Engineering/Clinical Operations, resolving issues that affect submissions and compliance timelines for projects.
What You Bring
Bachelor’s degree in a relevant scientific/engineering field.
3+ years combined experience in RA/QA for medical devices, including SaMD/IEC 62304 environments: working knowledge of 21 CFR 820, ISO 13485, ISO 14971 and IVDR.
Demonstrated contributions to successful regulatory submissions and to design‑control‑driven development.
Strong analytical, documentation, and cross‑functional communication skills; able to work autonomously under tight timelines.
We Want To Hear From You At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we’re looking for.
Equal Opportunity Employer PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that’s all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don’t tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.
Annual Pay Range $101,250 - $155,250
Not Overtime Eligible
Eligible for Equity
#J-18808-Ljbffr