Documentation Expert

Estimated Salary: $70,000 - $90,000 per year
At Vantage MedTech, we provide comprehensive design and manufacturing services to support the advancement of medical technologies. As a Documentation Specialist, you will work closely with development teams to ensure compliance with regulatory standards and maintain a Controlled Documentation Management System. The ideal candidate is a self-starter with a passion for being part of a team that improves people's lives.

The Key Responsibilities of this role include maintaining document control and record management systems, reviewing design history files for compliance, storing and cataloging controlled documents, ensuring internal audits are performed, controlling and maintaining regulatory standards, and providing general support for internal product development teams.

To be successful in this position, you should have a High School Diploma, 3-8 years of experience in document control and record management, preferably within the medical device development environment, and strong understanding of FDA regulations and ISO 13485. Excellent communication skills, both written and verbal, are essential for this role. You should also be detail-oriented, highly organized, and process-oriented, with the ability to work with a high volume of documents in a fast-paced environment.

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