Regulatory Document Control Specialist

Real Staffing; California (MO); On-site; USD 65,000 - 95,000; Full time

Job summary

Real Staffing is seeking a Document Control Specialist to manage controlled documents, records, and ECOs in a regulated medical device environment. The role ensures compliance with FDA 21 CFR Part 820 and ISO 13485, supporting audits and training while maintaining eDMS data integrity.

The successful candidate will collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing to support product development and quality initiatives.

Qualifications

• Bachelor's degree preferred.
• 5+ years of document control experience, preferably in the medical device, pharmaceutical, or regulated manufacturing industry.
• Knowledge of FDA regulations, ISO 13485, and electronic document management systems.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.

Responsibilities

• Maintain and control documents, including procedures, work instructions, specifications, and records.
• Administer document change requests and engineering change orders (ECOs).
• Ensure documentation complies with FDA 21 CFR Part 820, ISO 13485, and internal quality standards.
• Support audits by providing accurate and readily accessible records.
• Manage document training assignments and track completion.
• Maintain electronic document management systems (eDMS) and ensure data integrity.
• Collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing teams to support product development and quality initiatives.

Skills

Attention to detail

Organizational skills

Multi-priority management

Education

Bachelor's degree

Tools

Electronic Document Management System (eDMS)

Job description

Real Staffing is seeking a Document Control Specialist to manage controlled documents, records, and ECOs in a regulated medical device environment. The role ensures compliance with FDA 21 CFR Part 820 and ISO 13485, supporting audits and training while maintaining eDMS data integrity.

The successful candidate will collaborate with Quality, Regulatory Affairs, Engineering, and Manufacturing to support product development and quality initiatives.