Quality and Regulatory Compliance Manager | Manager Quality und Regulatory Compliance (m/w/d)
Roche Diagnostics GmbH
Job Summary
As a Quality and Regulatory Compliance Manager at Roche Diagnostics, you will serve as a strategic partner ensuring that medical innovations meet the highest standards of safety and excellence. Your day-to-day responsibilities involve maintaining and evolving Quality Management Systems (QMS) in accordance with ISO 13485, 14001, and 27001, while also overseeing audit and risk management processes. You will act as a regulatory expert, interpreting global and local laws for medical devices (MP) and in-vitro diagnostics (IVD), and leading cross-functional projects to implement new requirements. A unique aspect of this role is the responsibility for the Business Continuity Management (BCM) framework, where you will design emergency plans and conduct drills for the sales organization. This position is ideal for a proactive professional who enjoys working in a dynamic, international environment and wants to directly contribute to patient health by securing the compliance of life-saving diagnostic solutions.
Required Skills
Education
Successfully completed university degree in Natural Sciences or Engineering.
Experience
- At least 5 years of professional experience in a regulated environment (Medical Devices or In-Vitro Diagnostics)
- Professional experience in Quality Management and/or Regulatory Compliance
- Proven track record in organizing and executing cross-functional projects
- Experience in planning, conducting, and documenting audits with a qualification as an internal auditor
- Experience in implementing and maintaining international ISO standards
Languages
Additional
- The role requires regular physical presence at the Mannheim location. Applicants must provide a current CV and official educational certificates/transcripts.
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