Technical writer - Vaud, Schweiz - Michael Page Switzerland

Beschreibung

• International 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 various regulatory databases(e.g., GUDID in the USA, Saudi Arabia, Eudamed) using dataextraction tools.
• Coordinate changes includingtranslations of IFUs and organize product data in registrationdatabases across multiple countries.
• Collaborate closely with internal teams (R&D,Regulatory Affairs, Marketing, Purchasing) and external partners(translators, printers) to manage changes to IFUsefficiently.
• Gather and summarize keyinformation to manage updates to IFUs accurately andtimely.
• Ensure the regulatory compliance ofmedical devices in various markets worldwide.

Profile

• Previous experience (preferably 3-5 years) in themanagement of Instructions For Use for medical devices ordrugs.
• Familiarity withthe structure of technical documentation and proficient in usingAdobe Acrobat and Indesign for document modification.
• Skilled in using Excel for themanagement of product data in regulatory databases.
• Knowledge of ISO 13485:2016 andother relevant regulatory standards.
• Bachelor's degree in a relevant field(Technical Writing, Engineering, Regulatory Affairs, orsimilar).

JobOffer

Great opportunity to join anamazing team and take the lead on challengingprojects.