Exactech
Exactech is a medical technology company that empowers surgeons with innovative implants and smart technologies for joint replacement, enhancing patient mobility. The company offers a comprehensive range of products and solutions for knee, hip, shoulder, and ankle surgeries, supported by a dynamic ecosystem of enabling technologies and smart solutions to improve patient outcomes. Exactech emphasizes data-driven and low-cost solutions, serving the global medical community with its advanced surgical systems and educational resources. Its Active Intelligence platform and extensive research focus bring design excellence and operative insights to orthopedic practices worldwide.
Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation
Regulatory Specialist
September 25, 2024
Exactech
Exactech is a medical technology company that empowers surgeons with innovative implants and smart technologies for joint replacement, enhancing patient mobility. The company offers a comprehensive range of products and solutions for knee, hip, shoulder, and ankle surgeries, supported by a dynamic ecosystem of enabling technologies and smart solutions to improve patient outcomes. Exactech emphasizes data-driven and low-cost solutions, serving the global medical community with its advanced surgical systems and educational resources. Its Active Intelligence platform and extensive research focus bring design excellence and operative insights to orthopedic practices worldwide.
Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation
📋 Description
• The purpose of the Regulatory Specialist is to provide services to fulfill regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.
🎯 Requirements
• Bachelor’s Degree from an accredited institution required. • Minimum 2 years experience in FDA/ISO medical devices quality management system standards required • 2 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations preferred • Technical writing skills required • Experience in Design Controls • Working knowledge of windows-based office productivity tools including word processor and spreadsheet
🏖️ Benefits
• None
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