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Quality Compliance Manager

Company: VirtualVocations
Location: Gainesville
Posted on: November 8, 2024

Job Description:

A company is looking for a Quality & Regulatory Compliance Manager to ensure adherence to regulatory requirements and maintain the integrity of the quality management system.



Key Responsibilities

Lead continuous improvement of Information Security and Quality Management Systems
Oversee core assurance and compliance activities, including internal audits and regulatory body interactions
Develop and execute regulatory strategies to support product development and market approval


Required Qualifications

BS/MS (or equivalent) in a scientific discipline
At least four (4) years of experience in regulatory affairs or quality management systems for medical devices
Proficiency in ISO 13485:2016 and ISO 14971 standards
Familiarity with IEC 62304 life cycle requirements for software medical devices
Experience with US and international regulatory agency interactions and post-market reporting

Keywords: VirtualVocations, Spring Hill , Quality Compliance Manager, Executive , Gainesville, Florida

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