The role:
QA Resources is currently recruiting for a Tech Writer on behalf of a leading medical device company based in Limerick. This is a 12-month contract and a fully remote role.
Purpose:
We are seeking a detail-oriented Technical Writer (Remote) to develop a comprehensive set of technical, validation, quality, and operational documents for medical device development and regulatory submission. This role will support cross-functional teams by producing and organizing high-quality documentation aligned with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and EU MDR.
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.
* You will be responsible for authoring and/or editing the following documents:
* Project Specifications: URS, FDS, HDS, SDS, VP, RTM
* Qualification/Validation: IS, PQ, DQ, CSV performance test
* Process/Risk management: PFMEA, PCP, FAI
* Operations/SOPs: SOP, training plans, PM, Operations Log, Calibration Requests
* Inspection/Visuals: Visual Standards, Inspection Procedures, Inspection Guide Sheets
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.
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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