Our client is an international company specialized in medical devices.

Description

• 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.

Profile

• 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).

Job Offer

Great opportunity to join an amazing team and take the lead on challenging projects.