Remote Senior Manager - Medical Device Quality & MDR

Smartedge Client in Spain is seeking a Senior Manager (Product Quality Complaints & MDR) for a 100% remote role.

The candidate will lead PQC operations and Medical Device Reporting for US and global markets, ensuring compliant complaint intake, investigation coordination, and timely submissions.

The ideal candidate has deep regulatory experience (FDA 21 CFR Part 803, ISO 13485), hands-on MDR preparation, and the ability to mentor a cross‑functional team in a high‑volume environment while J-1880…