- International company
- Medical devices
- 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).
-
Technical writer
Gefunden in: Talent CH C2 - vor 15 Stunden
Michael Page Switzerland Vaud, SchweizInternational company · Medicaldevices · ClientDetails · Our client is aninternational company specialized in medicaldevices. · Description · Maintain Instructions For Use (IFU) for our medicaldevices, ensuring compliance with regulatory standards. · Register medical devices in v ...
-
Infrastructure Engineer, Citrix/VDI Expert H/F
Gefunden in: beBee S2 CH - vor 3 Tagen
CA Indosuez (Switzerland) SA Lausanne, Schweiz GanztagsInformations générales · Entité · Azqore est une entreprise internationale spécialisée dans l'externalisation de Systèmes d'Informations et dans le traitement d'opérations bancaires pour les acteurs de la Gestion de Fortune. Issue d'une union inédite entre deux leaders sur leur m ...
-
Windows System Engineer H/F
Gefunden in: beBee S2 CH - vor 5 Tagen
CA Indosuez (Switzerland) SA Lausanne, Schweiz GanztagsInformations générales · Entité · Azqore est une entreprise internationale spécialisée dans l'externalisation de Systèmes d'Informations et dans le traitement d'opérations bancaires pour les acteurs de la Gestion de Fortune. Issue d'une union inédite entre deux leaders sur leur m ...
Technical writer - Lausanne, Schweiz - Michael Page Switzerland
Beschreibung
Our client is an international company specialized in medical devices.
Description
Profile
Job Offer
Great opportunity to join an amazing team and take the lead on challenging projects.