Clinical Quality Manager (Class 3 Med Device)

Clinical Quality Manager - Fully Remote Direct Hire

Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.

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 xhyhwjd 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