EMEA Quality & Regulatory Leader

Siemens Healthineers; Madrid; Presencial; EUR 140.000 - 180.000; Jornada completa

Descripción de la vacante

Siemens Healthineers seeks a DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d) to lead QMS and regulatory activities across the EMEA region. You will drive regional strategies, champion a risk-based approach, and partner with leadership to ensure market access and sustainable growth.

You will serve as Quality Representative for assigned entities, oversee audits and inspections, and mentor a high-performing regional team, aligning with global standards.

Formación

• University degree in life sciences or engineering or a related field.
• Proven leadership experience in quality/regulatory roles within medical devices or pharma.
• Strong track record in QMS, regulatory submissions, inspections, and product safety.

Responsabilidades

• Define and execute regional regulatory strategy to support market access across the EMEA region.
• Lead QMS maintenance, QA/QA engineering, audits, CAPA, and risk management.
• Drive continuous improvement to enhance product quality and customer satisfaction.
• Partner with Commercial and Customer Services to ensure compliance across markets.
• Lead interactions with authorities and oversee multi-market regulatory activities.

Conocimientos

Fluent English

Leadership

Stakeholder management

Data analysis

Educación

University degree in life sciences/engineering

Descripción del empleo

Siemens Healthineers seeks a DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d) to lead QMS and regulatory activities across the EMEA region. You will drive regional strategies, champion a risk-based approach, and partner with leadership to ensure market access and sustainable growth.

You will serve as Quality Representative for assigned entities, oversee audits and inspections, and mentor a high-performing regional team, aligning with global standards.