Senior Regulatory and Quality Specialist

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. 

As the Senior Regulatory and 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, participate in audits as needed, and may be responsible for maintaining/managing key QMS processes (e.g., document control). 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.

• Regulatory strategy, submissions, reviews
  • Build and execute global regulatory plans; prepare and coordinate pre-subs, 510(k)s, de novos, PMAs, and ex-US filings; participate in agency interactions.  
  • Shape registration strategy and author the technical file/design dossier content in partnership with Product, ML, Clinical, and Engineering.
  • May review and approve product promotional material and customer notifications to ensure alignment with regulatory status.
• Quality system  
  • Maintain and improve QMS processes 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.
  • Participate as subject matter expert in customer audits, certification body audits and regulatory inspections as needed.
• 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.   
• Cross-functional enablement
  • Serve as the day-to-day RAQA partner to Product/ML/Engineering/Clinical/LabOps, resolving issues that affect project timelines.

• Experience:
  • 5+ years of progressive experience in regulatory affairs and quality assurance in IVD medical devices, preferably SaMD with AI/ML
  • Demonstrated participation in regulatory submissions for FDA Class II/III devices and some ex-US regulatory experience (e.g., EMA IVDR Class A-C); experience with CDx submissions is a plus
  • Working knowledge of global regulatory standards, including FDA QSR, ISO 13485, IVDR, and ISO 14971.
  • Experience authoring and reviewing QMS documentation (e.g., procedures, protocols, reports)
• Educational Background:
  • Bachelor’s degree in engineering, physical, or life sciences (advanced degree preferred)
• Skills & Competencies:
  • Strong organizational skills with the ability to manage multiple projects in a dynamic environment.
  • Ability to manage details effectively while contributing to broader regulatory strategies.
  • Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.
  • Demonstrated success working within and maintaining FDA/ISO compliant Quality Systems

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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