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Quality and Regulatory Affairs Manager (m/f/d)

Quality and Regulatory Affairs Manager (m/f/d)

Location: Munich, Germany 

Our client is a world-class centre for leukaemia diagnosis and research that operates in a cutting-edge environment. They place an emphasis on training their employees and improving their technology strategy as a fast-growing international and interdisciplinary company. Their goal is to apply cutting-edge molecular and IT-based approaches to define the future of haematological diagnostics and therapy.

 

Responsibilities:

 

  • You support the team in establishing a quality management system according to ISO 13485 and maintain it

  • You will prepare the company's own analyzes for approval as CE-marked in-vitro diagnostics and oversee the approval process

  • You are involved in the creation of the technical documentation and accompany the risk management assessment

  • You will regularly carry out internal audits independently and oversee the preparation, implementation and follow-up of external audits

  • You support the laboratory management in carrying out the management review

  • You create work and procedural instructions and act as an internal contact for questions related to quality management and regulatory affairs

  • You work together with the team to constantly improve the existing processes

 

What you bring:

 

  • You have a degree in life science (biomedicine, (human) biology, biotechnology or similar)

  • You have well-founded practical experience in quality management according to ISO 13485 and in the approval of in-vitro diagnostics

  • You are very familiar with the creation of documentation according to ISO 13485 and for the CE marking of in-vitro diagnostics

  • You are characterized by a very careful and responsible way of working

  • You enjoy working in a team

  • You have very good knowledge of English

  • A high level of commitment and your determination to work towards optimal patient care round off your profile

 

Benefits:

 

  • 30 days holiday

  • Great Training – Friendly and Supportive culture

  • Full-time Permanent Position

  • Great Location in Munich with Parking

  • Competitive Salary


If you are interested in applying, please contact Luke Fines.
Email: luke.fines@adaptivelifescience.com
Phone: +442045492962

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