QA Release & Compliance Lead (ISO/IVDR)

Jobtailor; Parets del Vallès; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Jobtailor in Spain seeks a highly capable QA/Regulatory Affairs professional to lead product release activities, ensuring ISO13485/IVDR/MDSAP compliance and effective document control. You will coordinate with Notified Bodies, labs and health authorities, manage quality notifications, and drive continuous improvement within the QMS.

The role requires a Bachelor's in Engineering or Health Sciences, 3+ years in QA/RA, strong auditing experience, and excellent cross-functional collaboration and

Formación

• Experience in regulated environments under ISO13485 and/or IVDR.
• Experience in audits and supplier audits.
• Excellent communication across multiple departments.
• Attention to detail and compliance with regulatory standards.
• Analytical judgement in impact assessments.
• Cross-functional collaboration with engineering, QA, regulatory and supply-chain.

Responsabilidades

• Manage product release activities, evaluating technical and documental compliance according to Technical Direction guidelines.
• Participate in the configuration of systems related to product release.
• Coordinate communications with Notified Bodies, reference laboratories and related stakeholders.
• Manage documentation storage, control and retrieval, including externally archived documentation.
• Handle document management quality notifications, ensuring proper tracking and workflow.
• Approve quality notifications after evaluating their impact on batch release and product status.
• Monitor the status of materials affected by quality notifications.
• Coordinate communications with Health Authorities regarding import/export activities.
• Issue and manage authorizations and official letters required for import/export processes.
• Ensure compliance with ISO 13485, IVDR and MDSAP.
• Act as internal auditor and participate in supplier audits.
• Participate in continuous improvement of the Quality Management System.

Conocimientos

Team management

Auditing

Quality assurance

Regulatory affairs

Communication skills

Attention to detail

Analytical ability

Cross-functional collaboration

English (C1)

Educación

Bachelor's Degree in Engineering

Bachelor's Degree in Health Sciences

Descripción del empleo

Jobtailor in Spain seeks a highly capable QA/Regulatory Affairs professional to lead product release activities, ensuring ISO13485/IVDR/MDSAP compliance and effective document control. You will coordinate with Notified Bodies, labs and health authorities, manage quality notifications, and drive continuous improvement within the QMS.

The role requires a Bachelor's in Engineering or Health Sciences, 3+ years in QA/RA, strong auditing experience, and excellent cross-functional collaboration and