Regulatory Specialist

September 25

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Exactech

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Orthopaedic • Medical Device • Orthopedic • Implant • Surgical Instrumentation

501 - 1000

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