Quality Compliance Intern at Terumo Medical Corporation assisting in regulatory compliance processes. Engaging with suppliers for compliance declarations and improving supplier responsiveness in the medical device sector.
About the role
- Quality and Regulatory Affairs Manager developing and supporting quality management systems for medical devices. Engaging in regulatory processes and facilitating innovation in healthcare.
Responsibilities
- Support and further develop the quality management system in accordance with DIN EN ISO 13485 and the EU AI Act
- Support national and international approval and registration processes
- Participate in the risk management process according to ISO 14971 across the entire product lifecycle
- Operational implementation of Post-Market Surveillance (PMS) and vigilance, including incident reporting and communication with regulatory authorities
- Handle CAPA, non-conformities and customer complaints, and follow up on corrective actions
- Support planning, execution and follow-up of internal and external audits as well as supplier qualification
- Contribute to the validation of computerized systems (CSV), including risk analysis, test planning, execution and documentation
Requirements
- Degree in a scientific or technical discipline (e.g., biomedical engineering, engineering, life sciences, quality management) or equivalent qualification
- At least 2 years of relevant professional experience in Quality Management and/or Regulatory Affairs in medical devices
- Solid knowledge of requirements under ISO 13485, ISO 14971 and the EU Medical Device Regulation (MDR), including practical experience in Post-Market Surveillance (PMS) and vigilance
- Experience handling CAPA, complaints and audit preparation
- Knowledge of Computerized System Validation (CSV) and working with electronic QMS; familiarity with ISO/IEC 27001 is a plus
- Structured, independent working style, analytical thinking, team spirit, and very good German and English skills
Benefits
- Attractive compensation that recognizes your performance
- Secure, permanent employment with 30 days of vacation
- Help shape the future in a highly motivated team
- Varied tasks with room for your ideas
- Position in a future-proof industry — resilient even in turbulent times
- Modern offices in Hamburg or Berlin with good transport links
- Flexible working hours for a healthy work–life balance
- Hybrid work model that gives you the freedom to choose between office and remote work
- Employee offers via Corporate Benefits
Job title
Job type
Experience level
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