What are the responsibilities and job description for the Head of Clinical Compliance and Regulatory Strategy position at Ruby Robotics?
About Ruby Robotics
We are a trailblazing healthcare technology company harnessing AI-driven diagnostics to improve patient outcomes. Our vision is to pioneer the field of pathology automation by developing innovative hardware and software solutions.
Job Role
The Head of Clinical Compliance and Regulatory Strategy will be responsible for shaping our clinical strategy, regulatory submissions, compliance, and interactions with regulatory agencies. This role demands a seasoned professional with extensive 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.
- In-depth expertise in FDA regulations, ISO 13485, and clinical trial design.
- Proven ability to manage clinical trials, regulatory submissions, and compliance activities.
Our Culture
- Dynamic and collaborative work environment.
- Passionate and innovative team members.
- Opportunities for growth and leadership in a rapidly evolving industry.
