Quality management system (iso 13485, iso 14001, iso 27001)
Audit and risk management
Regulatory compliance (ivd, medical devices)
Roche UK is seeking a Manager of Quality and Regulatory Compliance in Mannheim, Germany. The ideal candidate will have extensive experience in quality management systems and regulatory compliance within a regulated environment, with a focus on continuous improvement and strategic collaboration
Job Summary
You will be involved in the maintenance, further development, and continuous improvement of the Quality Management System according to ISO 13485, ISO 14001, ISO 27001.
You will actively observe trends and changes in relevant global and local laws and take responsibility for interpreting and implementing these requirements.
As an expert, you will advise business areas on Quality, Regulatory, and Compliance issues and conduct employee training on these topics.
Matching Summary
Match Score: 85
Roche UK is seeking a Manager of Quality and Regulatory Compliance in Mannheim, Germany. The ideal candidate will have extensive experience in quality management systems and regulatory compliance within a regulated environment, with a focus on continuous improvement and strategic collaboration.
Skills & Requirements
Must-have
Quality Management System (ISO 13485, ISO 14001, ISO 27001)
Audit and Risk Management
Regulatory Compliance (IVD, Medical Devices)
Business Continuity Management Framework
Process improvement initiatives
Nice-to-have
Strategic partner to business areas
International team collaboration
Growth mindset and customer focus
Entrepreneurial and solution-oriented thinking
Key Requirements
Minimum 5 years of experience in regulated environment (MP, IVD)
Experience in Quality Management and/or Regulatory Compliance
Experience with ISO 13485, ISO 14001, ISO 27001
Qualification as an internal auditor
Proven experience in cross-functional projects
University degree in natural sciences or engineering