VP Clinical and Regulatory Affairs

ABOUT US

Started by Stanford/MIT serial entrepreneurs, Ruby Robotics is maximizing patient outcomes with tissue insights at the point of care. Using custom-built hardware and AI, our platform optimizes biopsy and surgical procedure workflow while delivering disease analytics early in the patient’s journey. This facilitates faster, more informed treatment decisions for patients as well as improved staffing and operational workflow for hospitals. Funded by healthcare and deep tech VCs, our team is lean, fast, and works intensely towards the goal of improving cancer patient care.

ABOUT THIS OPPORTUNITY

The VP of Clinical and Regulatory Affairs will be responsible for leading clinical strategy, regulatory submissions, compliance, and interactions with regulatory agencies (e.g., FDA, EMA). This role requires a strategic thinker and experienced operator with hands-on experience in medical device and software-as-a-medical-device (SaMD) regulatory pathways, particularly in AI-driven devices. This individual will also play a key role in developing and implementing quality strategies, ensuring regulatory compliance, and driving continuous improvement initiatives. The ideal candidate will work 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.

QUALIFICATIONS

• 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.
• Deep knowledge of FDA regulations, ISO 13485, and clinical trial design.
• 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.
• Entrepreneurial mindset with the ability to thrive in a fast-paced, early-stage startup environment.
• Experience with data analysis and statistical analysis

WHY JOIN US

• Opportunity to lead regulatory and clinical strategy for groundbreaking hardware and AI-driven pathology automation technology.
• Work with a passionate and innovative team at the forefront of digital pathology and AI-powered diagnostics.
• Competitive salary, equity, and comprehensive benefits package.
• A dynamic and collaborative work environment with opportunities for growth and leadership.

If you are a strategic leader passionate about shaping the future of pathology automation and AI-powered diagnostics, we encourage you to apply!

Ruby-Robotics is proud to be an equal opportunity employer. We are committed to offer a safe environment for our employees and do not discriminate based upon race, color, national origin, religion, sexual orientation, gender, gender identity and expression, age, veteran status, or disability.