What are the responsibilities and job description for the Regulatory and Clinical Strategy Lead position at Ruby Robotics?
About Ruby Robotics
We are a pioneering healthcare technology company leveraging AI-driven diagnostics to improve patient outcomes. Our mission is to transform the field of pathology automation by developing innovative hardware and software solutions.
Job Overview
The Chief Medical Device Regulatory Affairs Officer will be responsible for driving our clinical strategy, regulatory submissions, compliance, and interactions with regulatory agencies. This role requires a seasoned professional with hands-on experience in medical device and software-as-a-medical-device (SaMD) regulatory pathways, particularly in AI-driven devices.
Key Responsibilities
Qualifications
- 8 years of experience in clinical and regulatory leadership roles within the medical device and/or SaMD sectors.
- Proven track record of obtaining regulatory clearances for medical devices, preferably AI-based or pathology-related technologies.
- Expertise in FDA regulations, ISO 13485, and clinical trial design.
- Experience in managing clinical trials, regulatory submissions, and compliance activities.
What We Offer
- Opportunity to lead regulatory and clinical strategy for cutting-edge hardware and AI-driven pathology automation technology.
- Collaborative work environment with passionate and innovative team members.
- Dynamic and fast-paced work environment with opportunities for growth and leadership.
