What are the responsibilities and job description for the Medical Device and AI Regulatory Expert position at Ruby Robotics?
About the Team
Ruby Robotics is a dynamic and innovative team at the forefront of digital pathology and AI-powered diagnostics. We are passionate about improving cancer patient care and shaping the future of pathology automation.
The ideal candidate will have a strong background in clinical and regulatory leadership roles, with hands-on experience in medical device and SaMD regulatory pathways, particularly in AI-driven devices.
Responsibilities
- Develop and execute regulatory strategies to secure approvals for medical devices and AI-driven software.
- Lead the preparation, submission, and management of regulatory filings, including 510(k), De Novo, Breakthrough, and CE Mark.
- Act as the primary liaison with regulatory agencies, responding to inquiries, attending meetings, and negotiating approval pathways.
- Lead clinical strategy and trial execution, ensuring compliance with Good Clinical Practice (GCP) and applicable regulatory requirements.
- Develop and implement quality and compliance strategies aligned with ISO 13485, MDR, IVDR, and other applicable regulations.
- Oversee quality assurance and control activities, including risk management, CAPA, non-conformance investigations, and supplier quality management.
- Oversee internal and external audits, ensuring regulatory readiness and compliance.
- Collaborate with product, R&D, engineering, and commercial teams to align regulatory requirements with product development.
- Monitor evolving regulatory and clinical trends in AI-driven diagnostics and pathology automation to inform strategy and compliance.
- Establish and manage relationships with Key Opinion Leaders (KOLs), clinical research organizations (CROs), and external partners.
