Head of Regulatory and Quality

Head of Quality Management and Regulatory Affairs

Who are we looking for?

How important is developing your skills in Quality Management and regulatory affairs?

If the answer is very, then this might be a good role for you.

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.

What is important to understand is that 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 und business processes
• Fluent in German and English
• Life science/ Medical device Industry experience

If you would like to understand more about this role or have any questions, please feel free to reach out.