Regulated Document Control & Training Specialist

Remote Jobs; Raleigh (NC); On-site; USD 55,000 - 90,000; Full time

Job summary

Talentify in Raleigh, NC seeks a Document Control Specialist to manage the creation, revision, approval, and archival of controlled documents, ensuring accuracy and regulatory compliance. You will maintain training records, support change management, and coordinate with cross-functional teams to keep the documentation system current.

The role requires experience with document management systems (Arena PLM preferred), strong attention to detail, and proficiency with Microsoft Office.

Qualifications

• Associate's or Bachelor's degree in a technical, business, quality, or related field preferred.
• 2-5 years of experience in document control or quality within a regulated industry.
• Experience with controlled documentation, quality records, and electronic document management systems.
• Knowledge of FDA QSR, ISO 13485; EU MDR and 21 CFR Part 11 is preferred.

Responsibilities

• Administer and maintain document control and training management systems (Arena PLM).
• Manage document lifecycle: submission, routing, review, approval, publishing, revision, archival.
• Maintain document master lists, revision histories, templates, and controlled records.
• Support Change Management and verify document changes for proper filing.
• Ensure obsolete documents are removed and only current, approved docs are available.
• Maintain training matrices, plans, and records; support training assignments.
• Provide user training on document management systems and electronic signatures.
• Support audits, regulatory inspections, and audit preparation with required records.
• Identify opportunities to improve document control processes and system usability.

Skills

Detail oriented

Time management

Communication

Team collaboration

Regulatory compliance

Education

Associate's or Bachelor's degree

Tools

Arena PLM

PLM

eDMS

ERP

Microsoft Office

Job description

Talentify in Raleigh, NC seeks a Document Control Specialist to manage the creation, revision, approval, and archival of controlled documents, ensuring accuracy and regulatory compliance. You will maintain training records, support change management, and coordinate with cross-functional teams to keep the documentation system current.

The role requires experience with document management systems (Arena PLM preferred), strong attention to detail, and proficiency with Microsoft Office.