Document Control Specialist

2 weeks ago

Limerick, Limerick, Ireland beBeeMedical Full time €50,000 - €75,000

Documentation Specialist:

Job Overview

This is a 12-month contract role for a Documentation Specialist to develop comprehensive documentation for medical device development and regulatory submission.


Purpose

We are seeking a detail-oriented Documentation Specialist to produce high-quality documentation aligned with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and EU MDR.


Main Responsibilities
  • Create, edit, and finalize technical and regulatory documents required throughout the device lifecycle.
  • Collaborate with engineering, quality, regulatory, and manufacturing teams to gather and validate content.
  • Ensure documentation follows internal templates, regulatory standards, and good documentation practices.
  • Participate in content reviews and implement stakeholder feedback.
  • Organize deliverables and track completion milestones across the documentation suite.

Required Skills and Experience
  • Technical writing experience in the medical device or regulated healthcare sector.
  • Strong knowledge of documentation standards under FDA, EU MDR, ISO 13485, ISO 14971.
  • Proficiency with document authoring tools (e.g., Microsoft Word).
  • Experience with Class II or III medical devices.
  • Strong collaboration and communication skills.
  • Able to work independently and manage priorities across multiple documents and stakeholders.

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