eTMF Specialist for Medical Devices

Job Summary

A company is looking for an eTMF Specialist - Medical Device.

Key Responsibilities

• Implement and maintain a GCP- and ISO 14155-compliant TMF Management program for medical device clinical studies
• Act as TMF Subject Matter Expert (SME) for medical device study teams and perform quality checks on TMF documentation
• Conduct TMF audits and support sponsor/vendor oversight activities to ensure compliance with regulatory requirements

Required Qualifications

• 3-5 years of experience in medical device clinical research within an FDA-regulated environment
• Strong working knowledge of FDA 21 CFR Part 812, ISO 14155, and EU MDR clinical investigation requirements
• Experience with electronic Trial Master File systems, including document management processes
• Bachelor's degree in Life Sciences, Biomedical Engineering, Nursing, Regulatory Affairs, or related field
• Experience supporting sponsor and vendor TMF audits and regulatory inspections