Technical writer (IFU management)
- 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.
- 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).
Great opportunity to join an amazing team and take the lead on challenging projects.
Technical writer (IFU management)
Maintain Instructions For Use (IFU) for our medical devices, ensuring compliance with regulatory standards. Coordinate changes including translations of IFUs and organize product data in registration databases across multiple countries. Collaborate closely with internal teams (R&D, Regulatory Affair...
Technical writer (IFU management)
Maintain Instructions For Use (IFU) for our medical devices, ensuring compliance with regulatory standards. Coordinate changes including translations of IFUs and organize product data in registration databases across multiple countries. Collaborate closely with internal teams (R&D, Regulatory Af...
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