Documentation Control Coordinator (contract)

TransMedics

Not specified; benefits: medical, dental, vision, ...
3-5 years documentation control experience
Fda 21 cfr part 820 and part 11 knowledge
Iso 13485 and eu mdr regulatory compliance
This contract role is critical for ensuring compliance with FDA, ISO 13485, and EU MDR regulations while supporting the implementation of an electronic Quality Management System

Job Summary

  • This contract role is critical for ensuring compliance with FDA, ISO 13485, and EU MDR regulations while supporting the implementation of an electronic Quality Management System.
  • The position involves managing the full document lifecycle including creation, review, approval, distribution, revision, and archival within a fast-paced medical device environment.
  • TransMedics offers a comprehensive benefits package including medical, dental, vision, 401K, and employee stock purchase plans to support their mission of saving lives through organ transplant therapy.

Matching Summary

This contract role is critical for ensuring compliance with FDA, ISO 13485, and EU MDR regulations while supporting the implementation of an electronic Quality Management System.

Salary

Not specified; Benefits: Medical, Dental, Vision, 401K, Employee Stock Purchase Plan

Skills & Requirements

Must-have

  • 3-5 years Documentation Control experience
  • FDA 21 CFR Part 820 and Part 11 knowledge
  • ISO 13485 and EU MDR regulatory compliance
  • eQMS platform deployment and configuration
  • Document lifecycle management activities

Nice-to-have

  • Medical device industry experience preferred
  • Experience with eQMS implementation projects
  • Knowledge of validation and change control processes
  • Strong attention to detail in regulated environments

Key Requirements

  • Minimum 3-5 years in Documentation Control role
  • High School Diploma required
  • Proficiency in Microsoft Office Suite and PDF editing tools
  • Working knowledge of FDA and ISO regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter