Global QA/RA Specialist – Medical Devices (EMEA)

Zimmer Biomet; Segrate; In loco; EUR 29.000 - 36.000; Tempo pieno

Descrizione del lavoro

Zimmer Biomet is seeking a QARA specialist to support ISO 13485 compliance and regulatory affairs across the EMEA region. You will help maintain the local QMS, drive CAPAs, and coordinate audits and recalls as needed.

The role requires 3+ years in registration/QA for medical devices or related fields, with strong English skills and experience with ISO standards. Competitive base salary is provided with potential bonus elements.

Competenze

• 3+ years’ experience in registration/notification activities and/or quality assurance in medical devices, pharma, or veterinary area.
• English language is a basic requirement, high standard of English speaking-writing skills.
• Knowledge of ISO13485 and MDR is a plus.

Mansioni

• Quality Management System (QMS) support across the assigned region.
• Regulatory Compliance and product registrations, renewals, and regulatory clearance.
• Complaint handling and investigation coordination.
• Manage Field Actions (Recalls) and report KPIs to management.
• Plan, participate in internal and external audits.

Conoscenze

Fluent English

Excellent communication

Organized

Autonomous

Formazione

Bachelor's or Master's in biomedical/clinical engineering, pharma, biological or medical science

Strumenti

Excel

PowerPoint

SAP

Descrizione del lavoro

Zimmer Biomet is seeking a QARA specialist to support ISO 13485 compliance and regulatory affairs across the EMEA region. You will help maintain the local QMS, drive CAPAs, and coordinate audits and recalls as needed.

The role requires 3+ years in registration/QA for medical devices or related fields, with strong English skills and experience with ISO standards. Competitive base salary is provided with potential bonus elements.