Quality Assurance
il y a 4 jours
**Quality Assurance & Regulatory Affairs Manager**
**Overview**
Our client has a major project connecting medical devices to the Cloud and with such a close-knit team, they are looking for a QA/RA Manager who would enjoy the challenge and growth in the position and organization.
**Tasks**
- Maintenance and futher development of the QMS in accordance to ISO 13485
- Ensure product quality and regulatory compliance with ISO 13485, MDR and any other regulatory requirements
- Training to employees, customers and suppliers on QA/RA topics
- Complaint handling and Post Market Surveillance activities
- Maintenance of entries in EUDAMED
- Manage Medical Device registrations
**Your profile**
- 3+ years professional experience in Medical Device Industry, especially in Quality Management
- Completed studies in Health Sciences/Engineering, or a comparable education
- Thorough knowledge of regulatory requirements such as ISO 13485, MDR etc.
- Good organizational and strong communication skills
- Diligent, responsible and independent working style
- Familiar with MS Office
- Fluency in English, German is desirable and French is advantageous
+49 30 1663 7750
**Job Types**: Full-time, Part-time
**Salary**: €65,000.00 - €80,000.00 per year
**Language**:
- English (required)
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