Remote Senior Manager - Medical Device Quality & MDR

Smartedge Solutions; España; A distancia; EUR 90.000 - 150.000; Jornada completa

Descripción de la vacante

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

Formación

• Deep regulatory experience in medical device PQC and MDR
• Hands-on experience with US FDA MDR requirements and global vigilance
• Experience leading cross-functional teams in a high-volume regulated environment

Responsabilidades

• Lead PQC and MDR activities for US and global markets
• Oversee complaint intake, triage, investigation, and reporting
• Ensure compliance with 21 CFR Part 803 and ISO/GDP standards
• Coordinate global vigilance submissions and country-specific reportability criteria
• Mentor and develop a high-performing team of quality/regulatory professionals

Conocimientos

PQC Management

MDR Expertise

FDA MDR Knowledge

Global Vigilance

Documentation & Inspection Readiness

Educación

Bachelor’s degree in Life Sciences / related discipline

Associates certification in Regulatory Affairs/Quality

Herramientas

ETQ

TrackWise

Veeva Vault

Salesforce

Descripción del empleo

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