Sr Manager, Clinical Compliance

Senior Manager, Clinical Compliance

📍 Remote | Medical Device

A growing structural heart medtech company developing a breakthrough minimally invasive treatment for valvular heart disease is seeking a Senior Manager, Clinical Compliance to support pivotal clinical studies and upcoming regulatory milestones.

Why this role?

• Lead the clinical compliance program for high-profile global trials
• Own audit strategy, inspection readiness, CAPA, and vendor oversight
• Serve as the key compliance partner between Clinical Affairs and Quality
• Manage and develop a direct report while helping scale the function
• Join a company at a pivotal stage of growth with potentially practice-changing technology

Key requirements

• 7+ years in Clinical Quality, Clinical Compliance, or Clinical Operations
• Strong GCP auditing experience (sites, CROs, vendors)
• Medical device experience preferred
• Expertise in FDA regulations, ISO 14155, CAPA, and inspection readiness
• Prior leadership experience highly desirable

This is an excellent opportunity for a clinical quality leader looking to make a significant impact on the development of innovative cardiovascular therapies.

If you believe you'd make a good fit for this role, please apply now.