Jobs at PathAI

• Understand the research and technologies that PathAI offers and the value proposition across customer segments with an ability to articulate easily to those with a basic level of understanding.
• Create launch plans for new Digital Diagnostics customer-facing product(s) or service(s) in partnership with Digital Diagnostics Product and Commercial teams including target customer identification, key messages, go-to-market plan, and market growth pathways.

• Regulatory Submissions and Documentation:

Prepare and manage regulatory submissions, particularly for FDA 510(k), PMA, and EMA IVDR filings, ensuring technical accuracy and compliance.
Organize technical files, design dossiers, and regulatory documentation for diagnostic products, including AI-driven and IVD devices.
File pre-submission requests and respond to inquiries from global regulatory bodies.
Author/write regulatory documents in support of our submission process.
Oversee regulatory operations, including the management of regulatory documentation, tracking of submissions, reporting, data analysis, and the development of dashboards or metrics to monitor and optimize regulatory processes.
Serve as a key point of contact with regulatory agencies, supporting regulatory submissions, pre-submissions, and addressing questions or additional information requests.

• Lead the development and implementation of platform product initiatives, collaborating closely with engineering, business, and design teams.
• Define clear product requirements, prioritize features, and work with cross-functional teams to ensure alignment and timely delivery.

• Python
• FastAPI & Django + DRF

• Python/Django
• Django REST framework

• Strategically engage biopharma and biotech sponsors to develop long-term enterprise-wide partnerships
• Represent PathAI as the primary point of contact for biopharma relationships assessing the client’s needs against PathAI products and services; connect biopharma partners to internal subject matter experts as needed

• Deeply understand PathAI’s portfolio and value proposition to translational research customers, and able to articulate it clearly to prospective customers during initial engagements
• Proactively seek new business opportunities in the market by utilizing a portfolio of sources (including leads generated from website and events) to identify new biotech customer prospects

• Python/Django
• Django REST framework

• Python
• FastAPI & Django + DRF