Technical writer (IFU management)

Critères de l'offre

• Métiers :

  • Technical writer - Technical documents

• Expérience min :

  • 3 à 5 ans

• Secteur :

  • Security & Police

• Diplômes :

  • BA (Bachelor of Arts) / BSc (Bachelor of Science)

• Compétences :

  • Technical documentation
  • Adobe

• Lieux :

  • Le Vaud

• Conditions :

  • Permanent contract
  • Full Time

Critères de l'offre

• Métiers :

  • Technical writer - Technical documents

• Expérience min :

  • 3 à 5 ans

• Secteur :

  • Security & Police

• Diplômes :

  • BA (Bachelor of Arts) / BSc (Bachelor of Science)

• Compétences :

  • Technical documentation
  • Adobe

• Lieux :

  • Le Vaud

• Conditions :

  • Permanent contract
  • Full Time

L'entreprise : Michael Page

Our client is an international company specialized in medical devices.

Voir toutes les offres de Michael Page

Description du poste

• 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.

Description du profil

• 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).