PathAI

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

Senior Regulatory and Quality Specialist

Translator

• Oversee execution of multiple translational research projects/contracts with key clients to meet company goals and strengthen partner relationships
• Oversee execution of multiple programs to drive company-wide scientific and business strategy
• Develop client relationships and pursue new opportunities to drive business growth
• Responsible for professional development of team of program / project managers / support staff
• Responsible for hiring and training activities
• Collaborate and liaise across internal stakeholders including the business development, product, and machine learning teams, providing hypotheses for novel biological insights and strategy roadmaps for project completion.

Director of Translational Research, Oncology

Machine Learning Engineer

• Improve patient outcomes with AI-powered pathology; work on ML algorithms for histopathology, translational research, labs, and clinical trials.
• Work closely with biomedical data science, product development, translational research, MLOps and platform engineering to develop and deploy models.
• Independently execute machine learning model development for research and product projects following ML best practices.
• Understand product requirements in biological and clinical context and propose changes to model design, product requirements, or analysis plans.
• Demonstrate mastery of established and state-of-the-art ML methods and uphold ML team best practices.
• Engage with team governance, documentation, knowledge sharing, hiring and onboarding initiatives.
• Identify technical limitations of the platform and propose solutions for core problems in digital pathology.
• Contribute to scientific strategy via abstract submissions, manuscript preparation, and creation of external materials.

Senior Regulatory and Quality Specialist

Director of Translational Research, Oncology

Machine Learning Engineer II