Senior QARA Specialist
Core
Ensures compliance with quality and regulatory requirements for medical devices, managing the QMS, regulatory documentation, and audits.
Role type
Senior Quality and Regulatory Affairs Specialist
Builds
Medical device quality and regulatory compliance systems
Domain
Medical Devices / In-vitro Diagnostics
Required skills
ISO 13485 QMS management, IVDR implementation, CAPA management, complaint handling, change control, supplier qualification, audit preparation and execution, regulatory documentation, PMS/PMPF, risk management
Preferred skills
Leadership experience, cross-functional project coordination
Technologies
DIN EN ISO 13485, IVDR (EU 2017/746)
Responsibilities
Maintain and develop the QMS per ISO 13485; coordinate CAPAs, complaints, and change procedures; prepare for and accompany internal and external audits; create and maintain regulatory documentation for product registration; support IVDR implementation; collaborate with R&D, production, and sales on regulatory reviews
Seniority
Senior, hands-on IC