Head of Quality Management and Regulatory Affairs
Who are we looking for?
We are looking for a very special individual, someone with a background in RA/QA who understands medical device regulations but also has a detailed understanding of GMP and Bioprocessing.
This role will lead both the operations and the strategy of this department. The ideal person will have a strong cross-functional experience and have a “hands-on” approach to strategic leadership.
You will be tasked with establishing the Quality system and Regulatory processes for the department including CAPA management, Regulatory affairs, complaint management, and Quality management.
What will you need?
* Deep knowledge in Q-Systems ISO 9001, 13485, GMP, beneficial experiences with UD FDA 21 CFR Part 820 Quality Systems Regulation
* At least 10 years of experience in the Life Science or Medical Device industry
* Many years of experience in the design and implementation of QM systems and business processes
* Fluent in German and English
* Life science/ Medical device Industry experience
Seniority level
Director
Employment type
Full-time
Job function
Medical Equipment Manufacturing and Hospitals and Health Care
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