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 with team members to ensure complete and current technical documentation, maintain both paper and electronic records, and enforce compliance with applicable standards. This role also involves supporting regulatory, customer, and internal audits, and assisting with general tasks to improve the Quality Management System. The ideal candidate will possess an Associate's degree or equivalent experience, 2-4 years in a regulated industry, and experience with Quality System Regulations. Excellent communication skills are essential. 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
• Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors
• Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance
• Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA
• Follows OSHA regulations, RadNet and site protocols, policies and procedures
• Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times
• Practices universal safety precautions
• Promotes good public relations on the phone and in person
• Adapts and is willing to learn new tasks, methods, and systems
• Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines
• Consistently adheres to the time management policies and procedures
• Completes job responsibilities in a quality and timely manner

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

Benefits

Remote setting