Work with us.
Well, it sounds like old news - but at Cellbox®, every day is different. We grow and develop together and everybody knows: teamwork makes the dream work. It does not matter who you are, where you come from or what you look like - as long as you are motivated to be a cut above the best. In the office, we speak a wild mixture between German and English, please have that in mind when submitting your letter of application. We make things differently and are looking forward to receiving a job application from you that makes you stand out from the crowd. Talk to you soon!
Customer is king!
Let’s be honest: Our business is working with people and we treat our customers as we’d like to be treated. It’s as simple as that!
There is a lot to do at Cellbox® and moving things forward is in the DNA of our people: Flat hierarchies, transparency and ownership can be expected from us.
It’s a team effort!
Be flamazing: Individual effort is important, but it's teamwork that makes the dream work.
IS THAT YOU?
QM AND REGULATORY AFFAIRS MANAGER
Cellbox Solutions GmbH is a young technology company focusing on new innovative solutions for the global BioTech industry. The company, founded in 2016, is a spin-off from Fraunhofer Research Institution for Marine Biotechnology and Cell Technology in Lübeck. We’re aiming at improving the lives of others by providing innovative and new cell logistic solutions for the correct handling of living cells and biologic structures. To support our team in Hamburg we’re currently looking for a
QM AND REGULATORY AFFAIRS MANAGER (FULLTIME)
• Development of new products in cooperation with R&D and production
• Close collaboration with R&D and Production to assure compliance of locally manufactured products to international regulations
• Responsibility for product registrations on national and international level
• Establishment of QM system
• Creation and maintenance of Technical documentations for CE-certifications of laboratory and medical equipment (according to MDR)
• Elaboration of requirements for international markets
• Development of internal strategies for elaborating respective regulatory approval documents
• Correspondence with national/international authorities
• Preparation and control of export registrations
• Participation in audits
WHAT YOU'RE OFFERING:
• Degree in Regulatory Affairs, MedTech, Natural Sciences, Engineering or equivalent
• Several years of professional experience in the area of Medical Devices Regulatory Affairs or Quality Management for Medical Devices or Product Management of innovative technologies in Life Sciences
• Profound knowledge in Quality Management (ISO 13485) and Risk Management (ISO 14971)
• Ideally experienced in legal directives (according to MDR/IVDR)
• Experienced in regulatory approval processes of laboratory and medical products
• Excellent communication and presentation skills
• Hands-on mentality
• Fluent in German and excellent English language skills
WHAT WE'RE OFFERING:
• The opportunity to shape and build the QM department of a promising and growing technology company
• Permanent contract
• Motivated and experienced team, flat hierarchies
• Office in the heart of Hamburg, sports facilities and fresh fruit
READY FOR BOARDING?
Drop your application at jobs(at)cellbox-solutions.com. In case you have questions get in touch with Hans Nagels at +49 176 10 350 320. We’re looking forward to receiving your application.
YOUNG AND WILD
INTERNSHIP IS CALLING!
You have the motivation and drive to help Cellbox Solutions revolutionize biopharmaceutical Supply Chain Programs? You’re currently on the road to becoming a Life Science Revolutionary and would like to earn some practical experience as a Cellbox-Trainee? We offer internship placements in an innovative start-up atmosphere. One thing upfront: it won’t get boring. Promise.Give Us A Shout
NO OPEN VACANCIES?
YOU ARE WANTED ANYWAY.
Maybe we’re looking for you, but simply aren’t aware of it yet. Tell us why you think you are the missing piece in the jigsaw puzzle and don’t forget to attach your CV. We’d love to hear from you.Join In