Remote Document Control Specialist

Summary

Join our team as a Document Control Specialist and lead the maintenance and continuous improvement of our Document Management System (DMS). You will work collaboratively to ensure complete and current technical documentation, maintain both electronic and paper records, and enforce compliance with applicable standards. This role involves supporting audits, assisting with general quality system tasks, and interacting with regulatory authorities. The ideal candidate possesses an Associate's degree or equivalent experience, 2-4 years in a regulated industry, and strong communication skills. This is a remote position.

Requirements

• Associate’s degree in relevant field (or equivalent experience)
• 2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred) as a document control specialist
• Experience creating and maintaining both paper and electronic records
• Basic knowledge and understanding of Quality System Regulations, including but not limited, to 21 CFR 11, 21 CFR 820, and ISO 13485
• Experience interacting with Regulatory Authorities
• Excellent written and oral communication skills, including English

Responsibilities

• Lead the maintenance and continuous improvement of the Document Management System (DMS)
• Work with team members to ensure technical documentation and filings are complete and reflect current practice
• Ensure maintenance of technical and business related documentation, including routing, approval, and storage of electronic records
• Enforce compliance to applicable standards and escalate to appropriate authorities if needed
• Support regulatory, customer, and internal audits
• Assist in general tasks to support the maintenance and improvement of the Quality Management System

Preferred Qualifications

FDA and Software as a Medical Device

Benefits

Remote setting