PathAI

Senior Regulatory and Quality Specialist

PathAI

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Senior

About the role

  • Ensure 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
  • Represent RAQA in company-specific projects for diagnostic and clinical development services
  • Maintain/manage key QMS processes (e.g., document control) and improve QMS aligned to FDA QSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304
  • Provide risk and regulatory assessments during design control and change control activities
  • Participate as subject matter expert in customer audits, certification body audits and regulatory inspections as needed
  • 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 technical file/design dossier content in partnership with Product, ML, Clinical, and Engineering
  • Review and potentially approve product promotional material and customer notifications to ensure alignment with regulatory status
  • Guide teams through design inputs/outputs, V&V, risk management, usability, design transfer, and clinical/labeling impacts
  • Serve as the day-to-day RAQA partner to Product/ML/Engineering/Clinical/LabOps, resolving issues that affect project timelines

Requirements

  • 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/21 CFR 820, ISO 13485, IVDR, and ISO 14971
  • Experience authoring and reviewing QMS documentation (e.g., procedures, protocols, reports)
  • Bachelor’s degree in engineering, physical, or life sciences (advanced degree preferred)
  • 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