What are the responsibilities and job description for the Regulatory Affairs Manager position at Atraverse Medical, Inc.?
Role Summary
This role requires an experienced Quality Engineer to develop and maintain quality management systems, implement processes to improve quality, and respond to customer complaints.
Main Responsibilities
- Perform gap analysis of external standards (e.g., ISO 13485).
- Lead supplier audits based on risk management processes.
- Develop comprehensive Risk Assessment files for new products.
- Create and review quality and regulatory documents.
What We Offer
- Opportunity to work on innovative medical devices impacting patient outcomes.
- Comprehensive health, dental, and vision benefits.
