Remote Part-Time Risk Manager — Medical Devices & QMS

Ambit Iberia; Barcelona; A distancia; EUR 30.000 - 50.000; A tiempo parcial

Descripción de la vacante

A multinational pharmaceutical service provider is seeking a part-time Risk Manager (Medical Devices) to support various quality assurance activities. The ideal candidate should have over 5 years of experience in Quality Management, specifically with QMS and Risk Management, and knowledge of relevant EU regulations. This role allows for 100% remote work and requires fluency in English, with Spanish being highly valued. Candidates will manage the quality aspects of digital projects, ensuring compliance and excellence.

Formación

• 5+ years in Quality Management, Design Control, and Risk Management for software/in vitro diagnostics/medical devices.
• Experience with ISO 13485 and ISO 14971 standards.
• Knowledge of EU regulations: MDR and IVDR.

Responsabilidades

• Support the Risk and DQA team in their activities.
• Ensure quality assurance of digital projects is met.
• Promote compliance with the quality system.

Conocimientos

Quality Management System (QMS)

Risk Management

Regulatory Documentation

English (Fluent)

Spanish (Highly valued)

Descripción del empleo

A multinational pharmaceutical service provider is seeking a part-time Risk Manager (Medical Devices) to support various quality assurance activities. The ideal candidate should have over 5 years of experience in Quality Management, specifically with QMS and Risk Management, and knowledge of relevant EU regulations. This role allows for 100% remote work and requires fluency in English, with Spanish being highly valued. Candidates will manage the quality aspects of digital projects, ensuring compliance and excellence.