Regulatory Affairs Associate for managing new drug registrations and preparing documentation in the India Market. Collaborating with stakeholders and supporting compliance in bulk drug registration.
About the role
- Quality and Regulatory Affairs Manager working at TCC GmbH in Hamburg. Ensuring compliance with regulations and standards in medical technology within a motivated team.
Responsibilities
- Support and further development of the quality management system according to DIN EN ISO 13485 and the EU AI Act
- Support for national and international approval and registration processes
- Participation in the risk management process according to ISO 14971 across the entire product lifecycle
- Operational implementation of Post-Market Surveillance (PMS) and vigilance, including reporting procedures and communication with authorities
- Handling of CAPA, nonconformities and customer complaints, as well as tracking of corrective and preventive actions
- Support in the planning, execution and follow-up of internal and external audits, as well as supplier qualification
- Participation in the validation of computerized systems (CSV), including risk analysis, test planning, execution and documentation
Requirements
- Degree in a scientific or technical field (e.g., medical technology, engineering, biosciences, quality management) or equivalent qualification
- At least 2 years of relevant professional experience in quality management and/or regulatory affairs in the medical technology sector
- Solid knowledge of the requirements of ISO 13485, ISO 14971 and the EU Medical Device Regulation (MDR), including practical experience in Post-Market Surveillance (PMS) and vigilance
- Experience with CAPA, complaints handling and audit preparation
- Knowledge of Computerized System Validation (CSV) and experience with electronic QMS; knowledge of ISO/IEC 27001 is a plus
- Structured, independent working style, analytical thinking, team spirit, and very good German and English language skills
Benefits
- Competitive compensation that recognizes your performance
- Secure, permanent employment with 30 days of annual leave
- Opportunity to shape the future as part of a highly motivated team
- Varied tasks with room for your ideas
- Job in a future-proof industry — stability even in turbulent times
- Modern offices in Hamburg or Berlin with good transport connections
- Flexible working hours for a balanced work-life integration
- Hybrid work model giving you the freedom to choose between office and remote work
- Employee discounts and offers via Corporate Benefits
Job title
Job type
Experience level
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Not specified
Degree requirement
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