Regulatory Specialist - Remote

Overview

The purpose of the Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.

In Short

• Preparing and maintaining FDA pre-market submissions and Canadian device license applications.
• Assisting in preparing and submitting MDD Class III Design Dossiers.
• Providing regulatory support for new product development projects.
• Ensuring compliance with FDA and ISO/EC/CMDR certification.
• Participating in complaint handling and internal quality audits.
• Applying Exactech’s Quality Management System.
• Supporting different business units within regulatory guidelines.
• Assisting and supporting other employees and sales personnel.
• Practicing Exactech’s Values.

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 preferred.
• Technical writing skills required.
• Experience in Design Controls.
• Working knowledge of office productivity tools.

Benefits

• No specific benefits mentioned in the job description.