Regulatory Document Control Specialist

Mainstream Medical Devices, LLC; Austin (TX); On-site; USD 45,000 - 65,000; Full time

Job summary

Mainstream Medical Devices, LLC is seeking a Document Control Specialist to manage controlled documents and records in compliance with ISO 13485 and FDA QMSR. You will handle DCOs, label printing, and record storage, while supporting audits and light incoming inspection of parts.

The role requires meticulous attention, 1+ year in a regulated setting, and fluency in English. High school diploma required; MS Office proficiency is expected.

Qualifications

• Experience in a regulated environment with controlled documents.
• Knowledge of ISO 13485 and FDA QMS regulations preferred.
• Proficient in Microsoft Office; able to interpret technical docs.

Responsibilities

• Manage document lifecycle and release change orders (DCOs).
• Maintain Medical Device Files and Batch Records for retrievability.
• Direct storage and archiving of physical and electronic records.
• Support internal/external audits by retrieving documentation.
• Print and verify production labels against specs with zero errors.
• Perform incoming inspection of parts and document results.

Skills

Document Control

QMSR Compliance

Audit Readiness

Labeling & Printing

Incoming Inspection

Microsoft Office

English Fluency

Independent Working

Education

High school diploma

Job description

Mainstream Medical Devices, LLC is seeking a Document Control Specialist to manage controlled documents and records in compliance with ISO 13485 and FDA QMSR. You will handle DCOs, label printing, and record storage, while supporting audits and light incoming inspection of parts.

The role requires meticulous attention, 1+ year in a regulated setting, and fluency in English. High school diploma required; MS Office proficiency is expected.