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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