Technical writer (IFU management) in Le Vaud

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).
Michael Page Vakant seit : 11.04.2024

1261 Le Vaud (VD) 100% Nach Vereinbarung Unbefristet

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

Firma: Michael Page International (Suisse) SA

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