Regulatory Specialist
September 25
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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