Clinical Quality Manager (Class 3 Med Device)

Clinical Quality Manager - Fully Remote Direct Hire

Help Shape the Future of Implantable Medical Devices

We're seeking an experienced Clinical Quality Manager to lead quality assurance activities supporting global clinical development programs. This is a highly visible role responsible for ensuring compliance with GCP, FDA, MDR, ISO requirements, and maintaining the highest standards of patient safety and data integrity.

Key Responsibilities

✅ Integrate Clinical Quality processes into the Quality Management System (QMS)

✅ Lead risk-based clinical quality initiatives

✅ Oversee:

• GCP compliance
• Clinical quality audits
• Vendor qualification and oversight
• CRO performance management
• Quality agreements
• Regulatory inspection readiness

✅ Conduct audits of:

• Clinical sites
• CROs and vendors
• Trial Master Files (TMF)
• Clinical databases
• Pharmacovigilance systems

✅ Lead CAPAs, quality investigations, and continuous improvement initiatives

✅ Serve as the Clinical Quality representative across cross-functional clinical teams

✅ Develop and deliver GCP training programs

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, or related field
• Advanced degree preferred
• 5+ years of Clinical Quality Assurance experience
• Strong GCP background
• Experience supporting regulatory inspections
• Experience with electronic Quality Management Systems (eQMS)

Highly Preferred Experience

⭐ Implantable Medical Devices - Neuromodulation products would be a huge bonus

⭐ FDA, MDR, and ISO compliance

⭐ Clinical trial quality oversight

⭐ Clinical vendor and CRO management

⭐ Risk-based quality management programs

⭐ Inspection readiness and regulatory audits