Job Description

Noah Medical is seeking a Director of RA/QA to lead the Regulatory and Quality function throughout all stages of product development. This role involves establishing operational objectives, managing staff, developing company policies, and ensuring compliance with US and International regulatory requirements. The ideal candidate will be a motivated self-starter with excellent communication and team-building skills.

Responsibilities

• Establishes RA/QA department objectives and budgets
• Manages staff hiring, performance, and coaching
• Develops and executes RA/QA policies
• Manages RA/QA department functions
• Collaborates with senior management and external parties
• Defines, trains, and implements the quality management system (QMS)
• Coordinates regulatory activities
• Manages customer complaint reporting and investigations
• Serves as the designated Management Representative

Requirements

• BS degree (preferably in Engineering or Technology)
• 10+ years of RA/QA experience in the medical device field
• 3+ years of supervisory experience
• Experience in a startup environment
• Experience implementing a complete QMS system
• Experience with internal and supplier audits
• Self-starter with excellent communication skills

Benefits

• No benefits