What are the responsibilities and job description for the Regulatory and Clinical Strategist position at Ruby Robotics?
About the Role
Ruby Robotics is seeking an exceptional VP of Clinical and Regulatory Affairs to join our team. The successful candidate will have a proven track record in leading clinical and regulatory initiatives within the medical device and/or SaMD sectors.
This role offers a unique opportunity to shape the future of pathology automation and AI-powered diagnostics, working closely with internal stakeholders, regulatory bodies, and clinical partners to ensure successful product approvals and market entry.
Key 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.
