QARA Consultant - Diagnostics Software Specialist

EPM Scientific; Cantabria; A distancia; EUR 40.000 - 80.000; Jornada completa

Descripción de la vacante

An exciting opportunity has arisen for a QARA Consultant specializing in diagnostics software within the medical device sector. This fully remote role is perfect for a professional fluent in Spanish, who will ensure compliance with quality assurance regulations. The ideal candidate will leverage their deep knowledge of ISO 13485 and IEC 62304 standards to guide clinical evaluations and integrate Quality Management Systems, playing a crucial role in the lifecycle of diagnostic products. Join a forward-thinking company that values excellence in communication and compliance.

Formación

• Experience in quality assurance regulations specific to diagnostic software.
• Proficiency in implementing ISO 13485 and IEC 62304 standards.

Responsabilidades

• Implement ISO 13485 and IEC 62304 standards in product development.
• Guide clinical performance evaluations under IVDR guidelines.
• Integrate Quality Management Systems for regulatory compliance.

Conocimientos

Fluent Spanish communication

ISO 13485 understanding

IEC 62304 familiarity

Quality Management Systems experience

Descripción del empleo

QARA Consultant - Diagnostics Software Specialist

We are excited to announce a contract opportunity for an experienced QARA Consultant specializing 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 role 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 to effectively implement them across various stages of product development.
2. Guide clinical performance evaluations and analytic validations under IVDR guidelines, managing documentation processes related to IVDR (In Vitro Diagnostic Regulation).
3. Integrate Quality Management Systems that meet regulatory requirements while maintaining operational efficiencies throughout the diagnostic products' lifecycle.

Necessary Skills & Experience :

• Fluent Spanish communication skills are required, as the role involves frequent interactions.
• Deep understanding of ISO 13485 is critical for designing compliant systems efficiently.
• Familiarity with IEC 62304 standards, especially in medical device software development, including coding and testing phases.
• Hands-on experience implementing robust Quality Management Systems tailored to industry needs.