Hiring.fm
Pathai

Senior Product Quality & Regulatory Specialist

Boston, MA or Remote Full Time

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.  

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.  

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.  

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.   

The cash compensation outlined below includes base salary or hourly wage and on-target commission for employees in eligible roles. The summary below indicates if an employee in this position is eligible for annual bonus, overtime pay and equity awards. Individual compensation packages are tailored based on skills, experience, qualifications, and other job-related factors. 

Annual Pay Range:
$101,250 - $155,250

Not Overtime Eligible

Eligible for Equity

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