Beschreibung

You will lead the European audit team, ensuring product safety and regulatory compliance. By managing audits and driving process improvements, you'll protect patient welfare and advance quality standards.

Anforderungen

• •University degree, preferably technical field
• •Management experience and technical expertise
• •Knowledge of ISO 13485, MDR, QMSR
• •Experience with eQMS and MS Office
• •Customer- and service-oriented approach
• •Openness to creative solutions and feedback
• •Flexibility and adaptability
• •Independence, reliability, and implementation skills
• •Communication skills and regulatory handling
• •Business fluent English

Aufgaben

• •Lead the European audit management team
• •Manage team members technically and disciplinarily
• •Coordinate tasks and manage results transparently
• •Steer product safety and regulatory compliance strategies
• •Track strategies throughout the product life cycle
• •Decide on risk-based measures for deviations
• •Assess safety issues and regulatory non-compliance
• •Protect patient welfare and product safety
• •Fulfill international reporting and disclosure requirements
• •Communicate with authorities and notified bodies
• •Plan and conduct internal quality audits
• •Monitor ISO 13485 and MDR management systems
• •Lead and support external audits
• •Develop improvement and compliance measures
• •Drive change processes with specialist departments
• •Motivate and develop the team professionally

Tools & Technologien

Benefits