Quality and Regulatory Manager

This is a role where quality and regulatory work directly enables products to reach market. The Quality and Regulatory Manager will own our ISO 13485 system, lead audits, and guide regulatory strategy for new and existing medical device products.

Requirements

• Lead internal and external audits
• Own and maintain the ISO 13485 Quality Management System
• Support regulatory activities for medical device products
• Guide regulatory requirements for new product development
• Oversee CAPA, nonconformance management, and continuous improvement initiatives
• Maintain and improve quality documentation
• Support supplier qualification, monitoring, and quality agreements
• Train and support internal teams on quality system requirements and regulatory expectations
• Collaborate cross functionally with engineering, production, procurement, and business development
• Serve as the primary point of contact for quality and regulatory matters

Benefits

• Competitive compensation package
• Full benefits
• Paid vacation