Hybrid Quality & PRRC Manager, Medical Devices MDR

Life Science Recruitment; Dublin; Híbrido; EUR 80 000 - 110 000; Tempo integral

Resumo da oferta

Life Science Recruitment is supporting a specialty pharma company in Dublin City Centre, offering hybrid work. The Quality Manager and PRRC role focuses on QMS leadership, regulatory compliance, and partnership with authorities to ensure MDR and GDP standards are met.

The role requires experience with Medical Devices/MDR, MDSAP and ISO 13485, plus hands-on CAPA and audit coordination. Dublin-based, permanent position with hybrid working model.

Qualificações

• BSc in Life Science or related discipline.
• Experience working with Medical Devices and MDR knowledge.
• Knowledge of MDSAP, ISO 13485:2016, 21 CFR Part 820, GDP 2013/C343/01.

Responsabilidades

• Maintain and manage the Quality Management System (QMS) and SOPs.
• Lead audits and manage supplier/CMO relationships; ensure audit-readiness across MDR/GDP.
• Perform PRRC duties per EU Article 15 for Medical Devices.
• Oversee MDR/GDP documentation, supplier evaluations, and post-market surveillance activities.
• Prepare annual management reviews and report KPI metrics for the Quality Department.

Conhecimentos

Quality management

Regulatory awareness

CAPA process

Audit coordination

GxP knowledge

Formação académica

BSc in Life Science / related discipline

Ferramentas

ETQ

Descrição da oferta de emprego

Life Science Recruitment is supporting a specialty pharma company in Dublin City Centre, offering hybrid work. The Quality Manager and PRRC role focuses on QMS leadership, regulatory compliance, and partnership with authorities to ensure MDR and GDP standards are met.

The role requires experience with Medical Devices/MDR, MDSAP and ISO 13485, plus hands-on CAPA and audit coordination. Dublin-based, permanent position with hybrid working model.