Sr Manager, Clinical Compliance
Senior Manager, Clinical Compliance
đź“Ť 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.
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