Technical Documentation Specialist Role Overview
This is a 12-month contract position working remotely. The Technical Writer will develop comprehensive technical, validation, quality, and operational documents for medical device development and regulatory submission.
* Key Responsibilities:
o Create, edit, and finalize technical and regulatory documents required throughout the device lifecycle.
o Collaborate with engineering, quality, regulatory, and manufacturing teams to gather and validate content.
o Ensure documentation follows internal templates, regulatory standards, and good documentation practices.
o Participate in content reviews and implement stakeholder feedback.
o Organize deliverables and track completion milestones across the documentation suite.
Required Skills and Qualifications
* Strong knowledge of documentation standards under FDA, EU MDR, ISO 13485, and 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.