What are the responsibilities and job description for the VP Quality Compliance position at Ruby Robotics?
Join Ruby Robotics
We are a team of innovators at the forefront of digital pathology and AI-powered diagnostics. Our goal is to improve patient outcomes with tissue insights at the point of care.
Role Summary
The Vice President of Clinical and Regulatory Affairs will lead our clinical strategy, regulatory submissions, compliance, and interactions with regulatory agencies.
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.
Requirements
- 8 years of experience in clinical and regulatory leadership roles within the medical device and/or SaMD sectors.
- Proven success in obtaining regulatory clearances (510(k), De Novo, CE Mark, etc.) for medical devices, preferably AI-based or pathology-related technologies.
- Experience in managing clinical trials, regulatory submissions, and compliance activities.
- Strong leadership, communication, and negotiation skills, with the ability to engage with regulatory agencies, clinical stakeholders, and internal teams.
- Experience with data analysis and statistical analysis.
What We Offer
A unique opportunity to lead regulatory and clinical strategy for groundbreaking hardware and AI-driven pathology automation technology.
The chance to work with a passionate and innovative team at the forefront of digital pathology and AI-powered diagnostics.
An inclusive and diverse work environment where everyone is valued and respected.
