Technical writer (IFU management)
- International company
- Medical devices
Technical writer (IFU management)
Our client is an international company specialized in medical devices.
Description
- Maintain Instructions For Use (IFU) for our medical devices, ensuring compliance with regulatory standards.
- Register medical devices in various regulatory databases (e.g., GUDID in the USA, Saudi Arabia, Eudamed) using data extraction tools.
- Coordinate changes including translations of IFUs and organize product data in registration databases across multiple countries.
- Collaborate closely with internal teams (R&D, Regulatory Affairs, Marketing, Purchasing) and external partners (translators, printers) to manage changes to IFUs efficiently.
- Gather and summarize key information to manage updates to IFUs accurately and timely.
- Ensure the regulatory compliance of medical devices in various markets worldwide.
Profile
- Previous experience (preferably 3-5 years) in the management of Instructions For Use for medical devices or drugs.
- Familiarity with the structure of technical documentation and proficient in using Adobe Acrobat and Indesign for document modification.
- Skilled in using Excel for the management of product data in regulatory databases.
- Knowledge of ISO 13485:2016 and other relevant regulatory standards.
- Bachelor's degree in a relevant field (Technical Writing, Engineering, Regulatory Affairs, or similar).
Job Offer
Great opportunity to join an amazing team and take the lead on challenging projects.
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