Gerente de Ventas / Distribuidor Freelance de Marca Premium de Cosmética

Iridium Concesiones De Infraestructuras, S.A.; Comunidad Valenciana; A distancia; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An innovative firm is seeking a QARA Consultant specializing in diagnostics software for a fully remote role. The ideal candidate will ensure compliance with quality assurance regulations in the medical device sector. This position requires fluency in Spanish and expertise in ISO 13485 and IEC 62304 standards. You'll play a vital role in implementing effective quality management systems and guiding clinical evaluations under IVDR guidelines, contributing significantly to the lifecycle of diagnostic products. Join a forward-thinking company where your skills will make a real impact!

Formación

• Experience in quality assurance regulations specific to diagnostic software.
• Ability to guide clinical performance evaluations under IVDR guidelines.

Responsabilidades

• Implement ISO 13485 and IEC 62304 standards in product development.
• Integrate Quality Management Systems for regulatory compliance.

Conocimientos

Spanish Speaking

ISO 13485 Expertise

IEC 62304 Knowledge

QMS Implementation Proficiency

Descripción del empleo

QARA Consultant - Diagnostics Software Specialist

We are excited to announce a contract opportunity for an experienced QARA Consultant specialising in diagnostics software within the medical device sector. This role is fully remote and requires proficiency in Spanish, aligning with our commitment to excellent communication standards. The ideal candidate will play a crucial part by ensuring compliance through their expertise in quality assurance regulations specific to diagnostic software.

Key Responsibilities

1. Leverage deep knowledge of ISO 13485 and IEC 62304 standards towards effective implementation across various stages of product development.
2. Guide clinical performance evaluations and analytic validations under IVDR guidelines, effectively managing documentation processes related to IVDR (In Vitro Diagnostic Regulation).
3. Fully integrate Quality Management Systems that meet stringent regulatory requirements while maintaining operational efficiencies throughout the lifecycle of diagnostic products.

Necessary Skills & Experience

• Spanish Speaking: Ability must be at least working level as this position involves frequent communications requiring fluency.
• ISO 13485 Expertise: Deep understanding needed because it's critical for designing compliant systems efficiently.
• IEC 62304 Knowledge: Requires familiarity since you'll need skills applying these international standard engineering techniques specifically suited toward medical device software integration tasks like coding or testing phases.
• QMS Implementation Proficiency: Hands-on experience implementing robust quality management systems tailored perfectly according to industry needs.