Back Office Executive

Job Description:

 Prepare and maintain Technical Files and related documentation for medical devices.
Ensure compliance with GSPR (General Safety and Performance Requirements) under EU MDR 2017/745.
Develop and update Risk Management Files in accordance with ISO 14971.
Prepare and maintain IFU (Instructions for Use), PSUR (Periodic Safety Update Reports), and usability engineering documents.
Create, review, and manage QMS documents, including Quality Manual, SOPs, Procedures, Work Instructions, and Formats.
Support in preparing documentation for country-specific medical device registrations.
Assist in post-market surveillance and continuous improvement of product safety and compliance.
Collaborate with cross-functional teams to ensure regulatory and quality documentation is up-to-date and audit-ready.