Compliance

• 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

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