Quality & Regulatory Affairs Director - 2490

This opportunity as a Quality & Regulatory Affairs Director will lead quality and regulatory operations at BIOREP Technologies, a boutique medical device design and manufacturing partner supporting cardiovascular and electromechanical device programs. This role is responsible for maintaining and strengthening the company’s ISO 13485 Quality Management System, ensuring audit readiness, and supporting regulatory compliance across both internal products and customer manufacturing programs. The Director will oversee a small quality team while remaining hands-on with CAPA management, investigations, and continuous quality improvement initiatives.

Why You’ll Love This Role

• Opportunity to own and lead a highly respected ISO 13485 quality system in a regulated medical device environment
• High visibility and impact, working closely with executive leadership in a small, collaborative organization
• Ability to shape quality processes and support innovative medical device programs in a growing environment
  
  

Ideal Candidate Profile

• Experienced Quality leader from a medical device manufacturer or CDMO environment
• Comfortable operating as a hands-on leader who can manage systems while also executing key quality activities
• Strong communicator and collaborator who thrives in a small, team-oriented company