EMEA Quality & Regulatory Affairs Leader

henryschein; Madrid; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Henry Schein is seeking an experienced QA/RA professional to support EMEA-wide quality and regulatory operations. The role involves documenting policies, conducting regulatory visits and audits, and coordinating CAPA follow-up across multiple countries within the EMEA region.

The position offers home-based work with up to 30% travel, and requires strong knowledge of ISO 13485, GDP, and MDR/IVDR, plus fluency in English. You will partner with the Exec.

Formación

• Bachelor's degree in Life Sciences, Pharmacist, Biomedical Engineering, Business management or a related field.
• Knowledge of Quality Management Systems and Project Management.
• Experience with GDP, MDR/IVDR regulations is a plus.
• Validation of computerized systems and risk management knowledge is a plus.

Responsabilidades

• Supports EMEA-wide QA/RA operations and documents EMEA policies.
• Performs quality & regulatory visits or audits and issues gap analysis.
• Organizes regional meetings and tracks actions.
• Supports Exec. Director QA/RA EMEA and the QA/RA team.
• Maintains eQMS and Quality Document Management tools.
• Oversees change control activities and CAPA follow-up.
• Assists country QA/RA teams in compliance with GDP and MDR; supports product launches.

Conocimientos

Quality Management

Project Management

Regulatory Standards

Stakeholder management

English

Educación

Bachelor’s degree

Herramientas

eQMS

CAPA

Descripción del empleo

Henry Schein is seeking an experienced QA/RA professional to support EMEA-wide quality and regulatory operations. The role involves documenting policies, conducting regulatory visits and audits, and coordinating CAPA follow-up across multiple countries within the EMEA region.

The position offers home-based work with up to 30% travel, and requires strong knowledge of ISO 13485, GDP, and MDR/IVDR, plus fluency in English. You will partner with the Exec.